Italian Digital Primary Cardiovascular Prevention Study (CV-PREVITAL)

April 4, 2024 updated by: Centro Cardiologico Monzino

Digital Strategies in Primary Cardiovascular Prevention in the Italian Population

The CV-PREVITAL study is a randomised clinical trial (RCT) controlled versus usual-care designed to compare the effectiveness of a mobile health (mHealth) intervention with that of usual care in reducing specific cardiovascular (CV) risk factors (in the short term) and the occurrence of vascular events (in the long term). Promoted by the Italian Network of Cardiology (ICN, a cardiovascular research network promoted by the Italian Ministry of Health), in collaboration with the Consorzio Sanità (Co.S., an Italian consortium of general practitioners), CV-PREVITAL aims to develop an innovative model of cardiovascular primary prevention and to validate it in a very large sample of subjects and in 'real life' conditions.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

CV-PREVITAL is an RCT investigating whether an mHealth application (App) provided on top of usual care, can improve lifestyle habits and CV risk factor control in the short-term, and the incidence of major CV events in the long- term. Participants undergo two clinical visits, the first at baseline and the second after 12 months. During these visits, total cholesterol, HDL, LDL, triglyceride, HbA1c, blood pressure, heart rate, BMI and waist circumference are measured. In addition, using questionnaires provided digitally, participants self-report data on the following topics: adherence to the Mediterranean diet, salt intake, alcohol consumption, physical activity, current and previous smoking history, psychosocial profile, and sleep quality. Demographic information, including education, socio-economic status and ethnic origin are also obtained at baseline. Subjects in the intervention group also receive the credentials to download the App, which contains educational information on cardiovascular risk factors, diet, physical activity, lifestyle and psycho-behavioral aspects. Using ad hoc designed algorithms, the App delivers personalized prevention programs based on periodic messages providing advice, motivational reminders and support to improve lifestyle and risk factor control. When at baseline high levels of blood pressure, blood glucose or cholesterol are detected, the App support the participant in self-monitoring the clinical changes of such variables during the follow up. The efficacy of the intervention is evaluated at the12th month using a cardiovascular risk score developed ad hoc in an Italian population (Modified Moli-Sani Score). The ability of the intervention to maintain its effect over time and its effectiveness in improving clinical outcomes are assessed at the 7th year of follow-up. The cost-effectiveness of the intervention is also evaluated at the 7th year.

The study envisages the recruitment of 82,800 participants (aged ≥45y) nationwide. Of these, 50,000 are selected among those who daily access the GPs ambulatories associated to the Co.S. consortium. In order to assess whether the scheduled mHealth intervention can be effective also in settings different from the primary care, several specific cohorts in primary prevention are also enrolled by specialized units belonging to Scientific Institutes for Research, Hospitalization and Health Care (Italian acronym IRCCS). These cohorts include 32,800 subjects in total. Specifically, the UO-1 (IRCCS Cardiologico Monzino in Milan) enrolls 5,000 participants selected among citizens attending to community pharmacies; the UO-2 (IRCCS Auxologico in Milan) enrolls 5,000 subjects, 1,500 of which belonging to the Centre for Sleep Medicine; the UO-3 (IRCCS Humanitas in Milan) enrolls 2,000 subjects attending the institution; the UO-4 (IRCCS Mario Negri in Milan) does not recruit any subject but provides scientific and organizational support for the enrolment carried out by Co.S.; the UO-5 (IRCCS MultiMedica in Milan) enrolls 1,000 subjects with diabetes and 2,000 subjects from the general population; the UO-6 (IRCCS Neuromed in Pozzilli) enrols 10,000 subjects from the Neuromed clinical research centres; the UO-7 (IRCCS San Donato in Milan) enrolls 1,000 subjects selected among its own employees; the UO-8 (IRCCS Maugeri in Pavia) enrolls 1,000 subjects selected among its own employees; the UO-9 (IRCCS ISMETT, Mediterranean Institute for Transplantation and Advanced Specialized Therapies, in Palermo) enrolls 150 subjects who undergoes a physical activity program; the UO-10 (IRCCS San Martino in Genoa) enrolls 2,000 male subjects from the Municipality of Genoa; the UO-11 (IRCCS Ca' Granda of Milan) enrolls 2,000 blood donors afferent to its own Department of Transfusion Medicine and Hematology (DMTE); the UO-12 (IRCCS Gemelli in Rome) enrolls 1,000 subjects attending to the outpatient clinics of the Non-Invasive Cardiology Diagnostic Unit, of the Centre for Hypertension, and of the Centre for Endocrine and Metabolic Diseases; the UO-13 (IRCCS San Matteo in Pavia) enrolls 500 subjects selected among asymptomatic relatives of patients attending to the Policlinico San Matteo for cardiology reasons; the UO-14 (IRCCS San Raffaele in Rome) enrolls 150 subjects selected among its own employees.

Baseline data of the 82,800 participants and 1- and 7-years outcomes are also used to develop and validate a new algorithm for cardiovascular risk estimation. The new algorithm is developed by identifying among alcohol intake (as assessed by PREDIMED questionnaire), salt intake (as assessed by MiniSal questionnaire), perceived stress (as assessed by perceived stress scale (PSS), anxiety and depression (as assessed by Patient Health Questionnaire 4; PHQ 4), Locus of control (as assessed by Multidimensional Health Locus of Control scale, MHLCS), General Self Efficacy (as assessed by General Self Efficacy Scale; GSE), Risk propensity (as assessed by Risk Propensity Scale; RPS), and sleep quality (as assessed by Pittsburgh Sleep Quality Index) those variables that significantly improve the predictive power of the modified Moli-Sani algorithm.

The CV-PREVITAL trial also envisages a series of ancillary studies that are conducted by the various IRCCSs on the subjects already participating in the main study. Each ancillary study has its own protocol and aims, and foresees the evaluation of the role of further biomarkers relevant in the assessment of cardiovascular risk. The sub-study aims, outcomes information and time frame are described below. Baseline data of many ancillary studies are used to identify conventional and emerging determinants of specific cardiometabolic diseases. Specifically: a) the IRCCS Monzino analyses with multivariable approaches determinants and factors predisposing to diabetes status as assessed by Framingham diabetes score; b) the IRCCS Auxologico will apply additional elements for risk stratification including biomarkers high sensitive C-reactive protein (hs-CRP), Troponin I, N-terminal pro-brain natriuretic peptide (NT-proBNP), as well as 24 h ABPM (Ambulatory Blood Pressure Monitoring) derived variables; c) the IRCCS Humanitas analyses the frequency of genetic polymorphisms related to severe coronary calcification of its own cohort to identify genetic determinants of severe coronary calcification; d) the IRCCS MultiMedica analyses with multivariable approaches anthropometric (e.g. weight, height, BMI), biochemical data (e.g. lipid profile) and specific genetic disorders (e.g. presence of causative mutations in known genes involved in dyslipidemia) to identify determinants predisposing to dyslipidemia, hypertension and diabetes; e) the IRCCS Neuromed analyses with multivariable approaches determinants of dietary changes in the CV-PREVITAL Neuromed sub-study cohort; f) the Istituti Clinici Scientifici Maugeri IRCCS analyses baseline data of its own cohort with multivariable approaches to identify determinants of organ damage such as coronary silent ischemia, ankle brachial index, coronary calcium score and carotid ultrasound as well as Genetic and epigenetic (DNA and RNA) and other chemical determinants and factors predisposing to atherosclerotic diseases; g) the IRCCS Ca' Granda performs a 7 years validation of new monogenic and polygenic cardiovascular risk scores in its own primary prevention cohort. To this aim the study cohort is genotyped with GWAS and Whole Exome Sequencing (WES) for genetic factors influencing intracellular lipid handling (PNPLA3 I148M, TM6SF2 E167K, GCKR P446L, MBOAT7). Epigenetic variables indicated in the literature as early predictors of cardiovascular injury and cardiovascular events are also investigated. In addition to the characterization of genetic variants in known associated genes, the genomic characterization will allow the validation of candidate risk variants in genes reported to influence cardiovascular damage, the identification of potentially new candidate variants, and the calculation of polygenic cardiovascular risk scores and of their possible application to disease risk stratification in the Italian population; h) the IRCCS San Matteo develops new monogenic and polygenic scores and validates existing scores for the risk assessment of developing diabetes, hypertension and hypercholesterolemia.

Beyond the specific aims of the single sub-studies, a relevant goal common to all sub-studies is the collection of biological samples for the multisite biobank of the ICN.

The full list of approving body and approval number/ID of CV-PREVITAL studies is reported below.

Parent study: Approval Number: R1256/20-CCM 1319; Board Name: Comitato Etico degli IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino.

Ancillary studies of Monzino: Approval Number: R1579/21-CCM 1677 and R1617/22-CCM 1723; Board Name: Comitato Etico degli IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino.

Ancillary study of Istituto Auxologico Italiano: Approval Number: 2022_03_08_06; Board Name: Comitato Etico dell'IRCCS Istituto Auxologico Italiano.

Ancillary study of Humanitas: Approval Number: 2860; Board Name: Comitato Etico Indipendente dell'Istituto Clinico Humanitas.

Ancillary study of Multimedica: Approval Number: MM: 472.2021; Board Name: Comitato Etico IRCCS Multimedica - Sezione del Comitato Etico Centrale IRCCS Lombardia.

Ancillary study of Neuromed: Approval: Session of 28/09/2020; Board Name: Comitato Etico dell'Istituto Neurologico Mediterraneo Neuromed.

Ancillary study of San Donato: Approval Number: 197/INT/2021; Board Name: Comitato Etico IRCCS Ospedale San Raffaele.

Ancillary study of Maugeri: Approval Number: 2575 CE; Board Name: Comitato Etico degli Istituti Clinici Scientifici Maugeri.

Ancillary study of ISMETT: Approval Number: IRRB/16/22; Board Name: Comitato Etico IRCCS Sicilia.

Ancillary study of San Martino: Approval Number: 173/2021; Board Name: Comitato Etico Regionale della Liguria.

Ancillary study of Ca' Granda: Approval Number: 887_2020; Board Name: Comitato Etico Milano Area 2.

Ancillary study of Gemelli: Approval Number: 3614; Board Name: Comitato Etico della Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore.

Ancillary study of San Matteo: Approval Number: 2022-3.11/91 and 2022-3.11/493; Board Name: Comitato Etico Pavia.

Ancillary studiy of San Raffaele Roma: Approval Number: 21/21; Board Name: Comitato Etico IRCCS San Raffale Roma.

Update on Study Progress and Power Analysis: In its original design, the CV-PREVITAL study aimed to enrol approximately 80,000 subjects aged ≥45 years with no previous cardiovascular events. These participants were intended to be recruited from general practice clinics, pharmacies, or clinics of Scientific Institutes for Research, Hospitalization and Health Care (IRCCS). However, due to the challenges posed by the COVID-19 pandemic, which has fully engaged all parties involved in the study (primarily general practitioners, pharmacists, and IRCCS physicians), the planned activities of the study have been significantly delayed, especially in terms of participant enrollment. Despite these challenges, the study successfully recruited around 28,000 subjects, which is expected to be a sufficient number for evaluating the short-term primary endpoint. Specifically, to assess the short-term primary endpoint, a sample size of N=7895 per treatment arm is required, assuming a significance level of 0.05 and a power of 90%. Therefore, if the target of 16,000 subjects with completed follow-up is achieved, the study will have adequate power to reach the short-term primary endpoint. The estimation of the statistical power for the long-term endpoint will be carried out at the conclusion of the 7-year follow-up period when data regarding the actual dropout rate become available.

Study Type

Interventional

Enrollment (Actual)

27520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Abruzzo
      • Scafa, Abruzzo, Italy, 65027
        • Nucleo Cure Primarie Val Pescara
    • Calabria
      • Reggio Calabria, Calabria, Italy, 89132
        • Panacea Medical Group
    • Campania
      • Benevento, Campania, Italy, 82018
        • Samnium Medica
      • Salerno, Campania, Italy, 84083
        • MEDINCO'
      • Salerno, Campania, Italy, 84121
        • Magna Grecia
    • Emilia Romagna
      • Carpi, Emilia Romagna, Italy, 41012
        • Meditem
    • Friuli Venezia-Giulia
      • Pradamano, Friuli Venezia-Giulia, Italy, 33040
        • MAF
    • Isernia
      • Pozzilli, Isernia, Italy, 86067
        • IRCCS Neuromed
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs
      • Roma, Lazio, Italy, 00118
        • Arvamed
      • Roma, Lazio, Italy, 00163
        • IRCCS San Raffaele Roma
    • Liguria
      • Genova, Liguria, Italy, 16122
        • MediCoop Genova
      • Genova, Liguria, Italy, 16132
        • Ospedale Policlinico San Martino IRCCS
    • Lombardia
      • Bergamo, Lombardia, Italy, 24121
        • IML
      • Milano, Lombardia, Italy, 20122
        • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
      • Milano, Lombardia, Italy, 20138
        • Centro Cardiologico Monzino
      • Milano, Lombardia, Italy, 20149
        • Istituto Auxologico Italiano IRCCS
      • Pavia, Lombardia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Pavia, Lombardia, Italy, 27100
        • Istituti Clinici Scientifici Maugeri IRCCS
      • Rozzano, Lombardia, Italy, 20089
        • Humanitas Research Hospital IRCCS
      • San Donato Milanese, Lombardia, Italy, 22097
        • IRCCS Policlinico San Donato
      • Sesto San Giovanni, Lombardia, Italy, 20099
        • IRCCS MultiMedica SpA
    • Lombardy
      • Appiano Gentile, Lombardy, Italy, 22070
        • Medici Insubria
      • Legnano, Lombardy, Italy, 20025
        • GST
      • Milano, Lombardy, Italy, 20100
        • CMMC
      • Mozzate, Lombardy, Italy, 22076
        • Cosma 2000
      • Soresina, Lombardy, Italy, 26015
        • CMMG Soresina
    • Puglia
      • Martano, Puglia, Italy, 73025
        • Progetto Salute Soc. Coop
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • IRCCS Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
    • Toscana
      • Seravezza, Toscana, Italy, 55047
        • ARS Médica
      • Siena, Toscana, Italy, 53100
        • Medici 2000
    • Veneto
      • Padova, Veneto, Italy, 35100
        • Medigen Salute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects aged ≥ 45 years
  • Have given their consent to participate in the study
  • Subjects who have a smartphone

Exclusion Criteria:

  • Current or previous cardiovascular disease (personal history of myocardial infarction, angina pectoris, arterial revascularization procedures, stroke, TIA, peripheral artery disease)
  • Psychiatric disorders
  • Participation in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Subjects monitored following usual-care.
Experimental: Intervention group
Subjects in the intervention group, in addition to usual-care, will download a mHealth App that contains educational information promoting healthy lifestyle behaviours. The participant will be also able to self-monitor his/her clinical status regarding hypertension, diabetes or hypercholesterolemia.
Other: Mobile health application
The mHealth app delivers a personalized support program of digital health. Specifically, using ad hoc designed algorithms which uses the data self-reported by the subject and/or collected by the recruiter at baseline, the App delivers periodic messages with advice, motivational reminders and support to improve lifestyle habits and risk factor control.
Other Names:
  • mHealth app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular risk as assessed by Modified Moli-Sani risk score in the Italian population
Time Frame: 12 months
A score (modified Moli-Sani Risk Score) developed in the Italian population is used to analyze the efficacy of the intervention at 12 months. The risk score includes of blood pressure, HDL, LDL, triglyceride, blood glucose, overweight, physical activity, adhesion to Mediterranean diet and cigarette smoking. The modified Moli-Sani Risk Score may range from 0 to 100 and higher scores means higher risk. A 10% improvement in score between the baseline and final visit in the intervention group compared with the control group is assumed as indicator of intervention effectiveness.
12 months
Long-term CV clinical outcome at 7 years follow-up
Time Frame: 7 years
Incidence of a composite outcome including myocardial infarction (MI), stroke, transient ischemic attack (TIA), peripheral artery disease or CV death. In case of multiple vascular events only the first is used in the analyses of composite outcome, whereas the specific outcome (e.g. MI or stroke) is used when the sub-analyses focused on cardio- or cerebrovascular events are run.
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of a combined endpoint including hypertension, diabetes, hypercholesterolemia
Time Frame: 12 months
For each individual subject, the combined end-point will be calculated, at baseline and at month 12, as the number of variables out of target (according to last European Society of Cardiology guidelines), among blood pressure, HbA1c and blood cholesterol; therefore, its value will range between 0 and 3. The difference in the combined end-point between month 12 and baseline will be compared, between the two experimental groups, using Wilcoxon rank-sum test.
12 months
Systolic and diastolic blood pressure (mmHg)
Time Frame: 12 months
Comparison of the mean change from baseline in blood pressure in the two experimental groups.
12 months
HDL-C, LDL-C, and triglycerides (mg/dL)
Time Frame: 12 months
Comparison of the mean change from baseline in blood lipids in the two experimental groups.
12 months
HbA1c (%)
Time Frame: 12 months
Comparison of the mean change from baseline in HbA1c in the two experimental groups.
12 months
Body weight (kg)
Time Frame: 12 months
Comparison of the mean change from baseline in body weight in the two experimental groups.
12 months
Physical activity (IPAQ questionnaire)
Time Frame: 12 months
Comparison of the mean change from baseline in levels of physical activity as assessed by the short version (9 items) of the IPAQ (International Physical Activity Questionnaire) in the two experimental groups.
12 months
Mediterranean diet adherence (PREDIMED questionnaire)
Time Frame: 12 months
Comparison of the mean change from baseline in adherence to Mediterranean diet as assessed by PREDIMED (Prevention with Mediterranean Diet)" questionnaire in the two experimental groups. The PREDIMED score is a 14-item Mediterranean Diet adherence screener. Adherence is stratified in three categories: 1) low adherence (calculated score ≤5) 2) intermediate adherence (calculated score from 6 to 9), 3) high adherence (calculated score ≥10).
12 months
Mediterranean diet adherence (Moli-Sani questionnaire)
Time Frame: 12 months
Comparison of the mean change from baseline in adherence to Mediterranean diet as assessed by the Moli-Sani study questionnaire in the two experimental groups. The Moli-Sani Mediterranean diet adherence score may range from 0 to 21, the latter reflecting the maximal adherence to Mediterranean diet.
12 months
Smoking status
Time Frame: 12 months
Comparison of the mean change from baseline in cigarette smoking quantified by pack-years (number of packs of cigarettes smoked per day by the number of years the person has smoked) in the two experimental groups.
12 months
Alcohol intake
Time Frame: 12 months
Comparison of the mean change from baseline in alcohol intake as assessed by PREDIMED (''Prevención con dieta mediterránea'') questionnaire in the two experimental groups.
12 months
Salt intake (MiniSal questionnaire)
Time Frame: 12 months
Comparison of the mean change from baseline in salt intake as assessed by MiniSal questioner in the two experimental groups. The score may range from 0 to 11, the latter reflecting the maximal salt intake.
12 months
Stress (Perceived Stress Scale; PSS)
Time Frame: 12 months
Comparison of the mean change from baseline in perceived stress as assessed by PSS (Perceived Stress Scale) in the two experimental groups. The PSS scale may range from 0 to 40 and higher values means higher perceived Stress.
12 months
Psychological distress (PHQ 4 questionnaire)
Time Frame: 12 months
Comparison of the mean change from baseline in psychological distress as assessed by "Patient Health Questionnaire-4 (PHQ-4)" in the two experimental groups. The psychological distress PHQ-4 questionnaire may range from 0 to 12 and higher values means higher presence of the disorder.
12 months
Anxiety (PHQ 4 questionnaire)
Time Frame: 12 months
Comparison of the mean change from baseline in anxiety as assessed by "Patient Health Questionnaire-4 (PHQ-4)" in the two experimental groups. The Anxiety PHQ-4 questionnaire may range from 0 to 6 and higher values means higher presence of the disorder.
12 months
Depression (PHQ 4 questionnaire)
Time Frame: 12 months
Comparison of the mean change from baseline in depression as assessed by "Patient Health Questionnaire-4 (PHQ-4)" in the two experimental groups. The Depression PHQ-4 questionnaire may range from 0 to 6 and higher values means higher presence of the disorder.
12 months
Multidimensional Health Locus of Control Scale (MHLCS) - Internality
Time Frame: 12 months
Comparison of the mean change from baseline in locus of control as assessed by "Multidimensional Health Locus of Control Scale (MHLCS)-Internality" in the two experimental groups. The MHLCS-Internality may range from 6 to 36 and higher values means greater subject's internal locus of control.
12 months
Multidimensional Health Locus of Control Scale (MHLCS) - Powerful Others Externality
Time Frame: 12 months
Comparison of the mean change from baseline in locus of control as assessed by "Multidimensional Health Locus of Control Scale (MHLCS)-powerful-others-externality" in the two experimental groups. The MHLCS-powerful-others-externality may range from 6 to 36 and higher values means greater subject's external (dependent on others) locus of control.
12 months
Multidimensional Health Locus of Control Scale (MHLCS) - Chance Externality
Time Frame: 12 months
Comparison of the mean change from baseline in locus of control as assessed by "Multidimensional Health Locus of Control Scale (MHLCS)-chance-externality" in the two experimental groups. The MHLCS-chance-externality may range from 6 to 36 and higher values means greater external (case-dependent) locus of control of the subject.
12 months
General Self Efficacy (GSE Scale)
Time Frame: 12 months
Comparison of the mean change from baseline in general self-efficacy as assessed by "General Self Efficacy scale (GSE)" in the two experimental groups. The GSE scale may range from 10 to 40 and higher values mean greater self-efficacy perceived by the subject.
12 months
Risk propensity (RPS Scale)
Time Frame: 12 months
Comparison of the mean change from baseline in risk propensity as assessed by "Risk Propensity Scale (RPS)" in the two experimental groups. The RPS scale may range from 7 to 63 and higher values mean greater propensity to take risks.
12 months
Sleep quality (Pittsburgh Sleep Quality Index)
Time Frame: 12 months
Comparison of the mean change from baseline in sleep quality as assessed by "Pittsburgh Sleep Quality Index (PSQI)" in the two experimental groups. The PSQI may range from 0 to 21 and higher values mean lower sleep quality.
12 months
Subjects' adherence to data recording
Time Frame: 12 months
The App developed in the project collects information to analyse the participant's compliance with the data recording activities suggested by the app itself (blood pressure and blood glucose measurements, etc.). The subjects' adherence to data recording activities suggested by the app is assessed as the proportion of activities actually accomplished over the activities suggested.
12 months
Interruptions in the use of the mHealth App
Time Frame: 12 months
The App developed in the project provides functions able to assess the number of accesses over time of the participant and the actual use of the recommended tools. The interruptions in the use of the mHealth App is assessed as the number of weeks of lack of the actual use of the app.
12 months
Adherence to recommended therapies
Time Frame: 12 months
As part of the project, information on current therapies are collected in the eCRF at both baseline and 12 months. This information, together with the clinical/anthropometric data collected on the same occasions, will make it possible to ascertain whether a possible discontinuation of one of the therapies recorded at baseline is due to a improvement in the participant's clinical profile or to poor compliance. A poor adherence to recommended therapies is assessed by computing the frequency of non-medically justified therapy discontinuation.
12 months
Cost/effectiveness of intervention
Time Frame: 7 years
Incremental cost-effectiveness ratio (EUR/QALYs) calculated on the basis of costs related to intervention implementation (summation of costs of implementing and maintaining the IT platform, costs of the smartphone application, costs for healthcare professionals training for the use of the IT platform and costs for the involvement and education of participants) combined in an economic model with the QALYs (Quality Adjusted Life Years) modelled based on number of cardiovascular events (fatal and non-fatal) avoided during the seven years of follow-up.
7 years
House ownership as socioeconomic status indicator
Time Frame: 7 years
House ownership as socio-economic factor relevant to cardiovascular risk - proportion of subjects who are homeowners.
7 years
Type of residence as socioeconomic status indicator
Time Frame: 7 years
Type of residence as socio-economic factor relevant to cardiovascular risk - proportion of subjects living in urban (big or small city) or rural area.
7 years
Education as socioeconomic status indicator
Time Frame: 7 years
Education as socio-economic factor relevant to cardiovascular risk - proportion of subjects with: (1) no education (2) elementary education (3) Lower middle school (4) Higher middle school (5) Graduate (6) postgraduate).
7 years
Employment status as socioeconomic status indicator
Time Frame: 7 years
Employment status as socio-economic factor relevant to cardiovascular risk - proportion of subjects who: (1) have a full-time job, (2) work less than 5 days a week, (3) have a part-time job, (4) are disability pensioner, (5) are retired due to age limit, (6) are Partially retired, (7) are unemployed, (8) are Housewife.
7 years
Type of profession as socioeconomic status indicator
Time Frame: 7 years
Type of profession as socio-economic factor relevant to cardiovascular risk - proportion of subjects who are: (1) professionals, (2) teachers, (3) large business owners, (4) small business owners, (5) services, (6) employees, (7) laborers, (8) farmers, (9) Other.
7 years
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - history of hospitalization (questionnaire)
Time Frame: 7 years
History of hospitalization for SARS-CoV-2 infection as a risk factor for vascular events - proportion of subjects hospitalized for SARS-CoV-2 infection among those who develop or not vascular events over the 7-year follow-up period.
7 years
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - history of symptoms (questionnaire)
Time Frame: 7 years
History of symptoms for SARS-CoV-2 infection as a risk factor for vascular events - proportion of subjects with symptoms for SARS-CoV-2 infection among those who develop or not vascular events over the 7-year follow-up period.
7 years
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - history of asymptomatic disease (questionnaire)
Time Frame: 7 years
History of asymptomatic SARS-CoV-2, documented by at least one positive swab, as a risk factor for vascular events - proportion of subjects with at least one positive swab for SARS-CoV-2 infection among those who do or do not develop vascular events during the 7-year follow-up period.
7 years
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - history of vaccination (questionnaire)
Time Frame: 7 years
History of vaccination against SARS-CoV-2 infection as a protective factor for vascular events - proportion of subjects with at least one dose of vaccination against SARS-CoV-2 infection among those who do or do not develop vascular events during the 7-year follow-up period.
7 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in Oral Glucose Tolerance Test (OGTT) response in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: 12 months
Change compared to baseline in OGTT response in subjects of the CV-PREVITAL PREDIABETES sub-study cohort (1,000 subjects, including 200 with a diagnosis of type 2 diabetes mellitus (T2DM), 400 with a diagnosis of pre-diabetes and 400 normoglycaemic, randomized in the parent study).
12 months
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in insulinemia in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: 12 months
Change compared to baseline in insulinemia (µU/mL) in subjects of the CV-PREVITAL PREDIABETES sub-study cohort.
12 months
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in high-sensitivity C-reactive protein (hs-CRP) in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: 12 months
Change compared to baseline in hs-CRP (mg/L) in subjects of the CV-PREVITAL PREDIABETES sub-study cohort.
12 months
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in microalbuminuria in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: 12 months
Change compared to baseline in microalbuminuria [A/C ratio (mg/g creatinine)] in subjects of the CV-PREVITAL PREDIABETES sub-study cohort.
12 months
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in Estimated Glomerular Filtration Rate (eGFR) in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: 12 months
Change compared to baseline in eGFR estimated by serum creatinine values (mg/dL) in subjects of the CV-PREVITAL PREDIABETES sub-study cohort.
12 months
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in additional lipid parameters in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: 12 months
Change compared to baseline in fasting apolipoprotein B and lipoprotein(a) values (mg/dL) in subjects of the CV-PREVITAL PREDIABETES sub-study cohort.
12 months
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in diabetes diagnosis in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: 12 months
Proportion of subjects who changed from a diagnosis of T2DM to a diagnosis of pre-diabetes or from a diagnosis of pre-diabetes to a diagnosis of normoglycemia, compared to the baseline examination.
12 months
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): markers of carotid subclinical atherosclerosis in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: month 0
Comparison of baseline values of intima-media thickness (IMT) (mm); atherosclerotic plaque thickness (mm) and common carotid artery interadventitia diameter (mm) among normoglycemic, pre-diabetic and diabetic subjects.
month 0
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): carotid plaque area in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: month 0
Comparison of baseline values of total plaque area (mm2) among normoglycemic, pre-diabetic and diabetic subjects.
month 0
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): carotid plaque volume in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: month 0
Comparison of baseline values of total plaque volume (mm3) among normoglycemic, pre-diabetic and diabetic subjects.
month 0
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): carotid wall echolucency in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: month 0
Comparison of baseline values of echolucency (grayscale levels, 0-255) of carotid biggest plaques and echolucency of carotid IMT among normoglycemic, pre-diabetic and diabetic subjects.
month 0
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): endothelial function in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: month 0
Comparison of baseline values of endothelial function (reactive hyperemia index) measured by the EndoPAT device among normoglycemic, pre-diabetic and diabetic subjects.
month 0
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): peripheral atherosclerosis in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: month 0
Comparison of the prevalence of an impaired Ankle Brachial Index (ABI) between normoglycemic, pre-diabetic and diabetic subjects.
month 0
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): diabetic retinopathy in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: month 0
Comparison of the prevalence of diabetic retinopathy assessed by fundus retinography among normoglycemic, pre-diabetic and diabetic subjects.
month 0
Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): Long-term clinical outcome in the CV-PREVITAL PREDIABETES sub-study cohort
Time Frame: 7 years
Assessment of occurrence of cardiovascular events and overt diabetes over the 7-year follow-up period, depending on the length of time in prediabetes and the interaction of prediabetes with other risk factors (e.g. obesity, hypertension, hypertriglyceridemia, etc.).
7 years
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change of modifiable lifestyle-related cardiovascular risk factor such as smoking status, unhealthy diet and sedentary life in subjects of the Auxologico sub-study cohort
Time Frame: 12 months
Difference between App and control group in the proportion of subjects with any of the following characteristics: low adherence to Mediterranean diet (PREDIMED/MEDAS ≤ 8), or with low physical activity according to IPAQ (International Physical Activity Questionnaire) [nov.2005] or to be current smoker at 1 year after randomization.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in 24-h blood pressure in hypertensive subjects
Time Frame: 12 months
Comparison of the mean change from baseline in mean 24-h systolic BP in the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in body mass index in obese/overweight subjects
Time Frame: 12 months
Comparison of the mean change from baseline in mean BMI (height (m) and weight (kg) combined (kg/m2)) of obese subjects of the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in sleep quality in subjects with sleep complaints
Time Frame: 12 months
Comparison of the mean change from baseline in sleep quality as assessed by PSQI (Pittsburgh Sleep Quality Index) in the two experimental groups. The PSQI may range from 0 to 21 and higher values mean lower sleep quality.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in ambulatory blood pressure variables in hypertensive subjects
Time Frame: 12 months
Comparison of the mean change from baseline in mean 24-h systolic blood pressure (SBP), 24-h diastolic blood pressure (DBP), day-time SBP, day-time DBP, night-time SBP, night-time DBP, SD 24-h SBP, SD 24-h DBP, SD day-time SBP, SD day-time DBP, SD night-time SBP, SD night-time DBP, in the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12- month change in dipping status in hypertensive subjects
Time Frame: 12 months
Comparison of the mean change from baseline in the two experimental groups considering the dipping status defined as the difference between the mean systolic blood pressure in the day and mean systolic blood pressure during the night, expressed as a percentage of the day time mean, with the accepted normal between 10% and 20%.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in dietary salt intake in hypertensive subjects
Time Frame: 12 months
Comparison of the mean change from baseline of 24h sodium urinary secretion in hypertensive subjects of the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change of cardiovascular risk (in hypertensive and obese/overweight subjects)
Time Frame: 12 months
Comparison of the mean change from baseline in a cardiovascular risk score calculated according to clinical variables and biomarkers: Troponin I (cut off of 0.008 ng/mL), hs-CRP (cut off of 6.81 mg/L) and N terminal pro-BNP (cut off of 187 pg/mL) in the two experimental groups. The score will have a minimum of 0, high scores will mean high cardiovascular risk.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in microalbuminuria in hypertensive subjects
Time Frame: 12 months
Comparison of the mean change from baseline in microalbuminuria [A/C ratio (mg/mmol)] in the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in creatinine in hypertensive subjects
Time Frame: 12 months
Comparison of the mean change from baseline in creatinine (mg/dL) of the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in eGFR in hypertensive subjects
Time Frame: 12 months
Comparison of the mean change from baseline in eGFR [estimated by serum creatinine values (mg/dL)] of the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in left ventricular hypertrophy in hypertensive subjects
Time Frame: 12 months
Comparison of the mean change from baseline in presence/absence of left ventricular hypertrophy on ECG of the two experimental groups evaluated with Sokolow index and Cornell product.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month changes in acid uric level in hypertensive and obese/overweight subjects
Time Frame: 12 months
Comparison of the mean change from baseline in acid uric level (mg/dL) of the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month changes in fasting insulinemia (in obese/overweight subjects)
Time Frame: 12 months
Comparison of the mean change from baseline in fasting insulinemia (µU/mL) in the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month changes in fasting glucose levels (in obese/overweight subjects)
Time Frame: 12 months
Comparison of the mean change from baseline in fasting glucose levels (mg/dL) in the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month changes in waist circumference (in obese/overweight subjects)
Time Frame: 12 months
Comparison of the mean change from baseline in waist circumference (cm) in the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month changes in waist/hips ratio (in obese/overweight subjects)
Time Frame: 12 months
Comparison of the mean change from baseline in waist/hips ratio in the two experimental groups.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in Epworth Sleepness scale (ESS) questionnaire score (in subjects with sleep complaints)
Time Frame: 12 months
Comparison of the mean change from baseline in improvement in daytime sleepiness assessed by the Epworth Sleepness scale (ESS) questionnaire in the two experimental groups. The ESS has a minimum score of 4 and maximum of 24. Normal score ranges between 0 and 10.
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in obstructive sleep apnea (OSA) diagnosis (in subjects with sleep complaints)
Time Frame: 12 months
Difference in the percentage of patients diagnosed with OSA at 1 year after randomization in the two experimental groups; diagnosis of OSA is usually defined by polysomnographic indices like the apnea-hypopnea index (AHI) where AHI <5/hour = normal; 5-14.9/hour = mild OSA; 15-29.9/hour = moderate OSA; and ≥30/hour = severe OSA
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in positive airway pressure (PAP) treatment (in subjects with OSA treated with PAP therapy)
Time Frame: 12 months
Difference in the percentage of patients using positive airway pressure (PAP) devices at 1 year after randomization in the two experimental groups
12 months
Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in PAP treatment usage (in subjects with OSA treated with PAP therapy)
Time Frame: 12 months
Mean difference in the daily use of PAP devices at 1 year after randomization in the two experimental groups.
12 months
Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): 12-month change from baseline of cardiovascular risk in the CV-PREVITAL coronary calcium score sub-study cohort
Time Frame: 12 months
Comparison of 12-month change from baseline of cardiovascular risk between subjects randomized to screening by CT scanning to determine the CAC (Coronary Artery Calcium) score or traditional risk factor assessment alone. CAC score is calculated by the Agatston method and by the determination of the volume of calcium. The Agatston method assesses the weighted sum of lesions with a density above 130 Hounsfield unit (HU), multiplying the area of calcium by a factor related to maximum plaque attenuation: factor 1=130-199 HU; factor 2= 200-299 HU; factor 3= 300-399 HU; and factor 4= ≥ 400 HU. The calcium volume is calculated by multiplying the number of voxels with calcification by the volume of each voxel, including all voxels with an attenuation > 130 HU. The study has 2x2 factorial design: subjects are first randomized 1:1 to app or usual care; each subject is then randomized 1:1 to CT scanning on top of traditional risk factor assessment or traditional risk factor assessment alone.
12 months
Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): Rate of statin and aspirin therapy initiation in the CV-PREVITAL coronary calcium score sub-study cohort
Time Frame: 12 months
Comparison of the rate of statin and aspirin therapy initiation between subjects randomized to screening by CT scanning or traditional risk factor assessment alone.
12 months
Ancillary study of UO-3 (Humanitas Research Hospital IRCCS):12-month change in lipid biomarkers in the CV PREVITAL coronary calcium score sub-study cohort
Time Frame: 12 months
Comparison of 12-month change in lipid biomarkers between subjects randomized to screening by CT scanning or traditional risk factor assessment alone.
12 months
Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): SNPs associated with severe coronary artery calcification
Time Frame: 12 months
Assessment of the predictive ability for severe coronary artery calcification of SNPs, either identified in previous genome wide association studies or newly identified in this study.
12 months
Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): Incremental effectiveness, as assessed by healthy quality-adjusted life years (QALYs), of screening by CT scanning for coronary calcium score
Time Frame: 7 years
Incremental effectiveness (QALYs) calculated by multiplying Years of Life x Utility Value, assuming a utility value (quality of life) between 1=perfect health and 0=death.
7 years
Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): Incremental cost effectiveness ratio (ICERs) of screening by CT scanning for coronary calcium score
Time Frame: 7 years
Incremental cost effectiveness ratios (ICERs) calculated by dividing incremental costs (EUR) by incremental effectiveness (QALYs).
7 years
Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): long-term clinical outcome in the CV-PREVITAL coronary calcium score sub-study cohort
Time Frame: 7 years
Comparison of 7-year major adverse cardiovascular and cerebrovascular events between subjects randomized to screening by CT scanning or traditional risk factor assessment alone.
7 years
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in additional lipid parameters in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in apolipoprotein AI, apolipoprotein B and lipoprotein(a) values (mg/dL) in the sub-study cohort.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in glycemia in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in glycemia (mg/dL) in the sub-study cohort.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in Brain Natriuretic Peptide (BNP) in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in BNP (pg/mL) in the sub-cohort.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in creatinine evaluation in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in creatinine (mg/dL) of the two experimental groups.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in eGFR evaluation in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in eGFR (mL/min/1.73 m2) of the two experimental groups.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in microalbuminuria in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in microalbuminuria [A/C ratio (mg/g creatinine)] of the two experimental groups.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in hs-CRP in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in hs-CRP (mg/dL) of the two experimental groups.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in Interleukin 6 (IL-6) and Interleukin 1 beta (IL-1 beta) in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in IL-6 and IL-1 beta (pg/mL) of the two experimental groups.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in enzymatic tests in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in mean values (U/L) of the following enzymes: creatine phosphokinase (CPK), aspartate aminotransferase (AST), alanine transaminase (ALT) and gamma- glutamyltransferase (GGT) of the two experimental groups.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of Intimal-Media Thickness in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in the Intimal- Media Thickness (mm) measured by B-mode ultrasound of common in the two experimental groups.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of Intercellular adhesion molecule (ICAM) and Vascular Cell Adhesion Molecule (VCAM) in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in endothelial function measured by circulating levels of ICAM and VCAM (ng/mL) in the two experimental groups.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of Ankle Brachial Index in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in Ankle Brachial Index in the two experimental groups
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of total 10 year cardiovascular risk in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in the cardiovascular risk measured by an algorithm named "SCORE" (Systematic COronary Risk Evaluation)) in the two experimental groups. The Score may range from 0 to 100 and higher scores means higher risk.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of quality of life in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in the quality of life measured by the WHOQOL-Measuring Quality of Life questioner in the two experimental groups. The WHOQOL-Measuring Quality of Life questionnaire (World Health Organization Quality of Life - short version) is a questionnaire composed by 26 items that investigate four areas related to the quality of life (physical health, psychological, social relationships and environment). Answers are rated on a 5-point scale (from one to five, where one indicates disagree or never at all and five indicates completely agree or extremely; with the exception for items 3, 4, and 26 where the scoring need to be reverted). For each domain a mean score is obtained and then multiplied by 4 in order to transform the domain scores into a scaled score from 0 to 100. Overall, a higher score means a higher quality of life.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of psychological conditions risk in the sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in psychological conditions measured through Mini Mental Status Test in the two experimental groups.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): Coronary Calcium Score (Hounsfield units)
Time Frame: 12 months
Evaluation of Coronary Artery Calcium (CAC) score in patients with suspected familial hypercholesterolemia. CAC is detected by means of CT scanning as described by Agatston, who defined CAC as the product of the calcified plaque area and maximal calcium lesion density. Hecht et al., PMID=22672574 The CAC score is expressed with a number where 0 indicates the absence of coronary calcifications, from 1 to 400 the presence of coronary calcifications with a progressively higher risk (1-100 low, 101-400 moderate) and a score higher than 400 Hounsfield units a severe risk.
12 months
Ancillary study of UO-5 (IRCCS MultiMedica): Long-term clinical outcome in the sub-study cohort
Time Frame: 7 years
Assessment of occurrence of cardiovascular events, diabetes and hypertension over the 7-year follow-up period.
7 years
Ancillary study of UO-6 (IRCCS Neuromed): 12-month change in hs-CRP in the CV-PREVITAL Neuromed sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in hs-CRP (mg/L) in the CV-PREVITAL Neuromed sub-study cohort.
12 months
Ancillary study of UO-6 (IRCCS Neuromed): 12-month change in eGFR in the CV-PREVITAL Neuromed sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in eGFR estimated by serum creatinine values (mg/dL) in the CV-PREVITAL Neuromed sub-study cohort.
12 months
Ancillary study of UO-6 (IRCCS Neuromed): 12-month change in additional dietary habits assessed in the CV-PREVITAL Neuromed sub-study cohort
Time Frame: 12 months
Proportion of subjects who changed the consumption of ultraprocessed foods, according to the NOVA classification, compared to the baseline examination.
12 months
Ancillary study of UO-6 (IRCCS Neuromed): 12-month change in additional psycho-emotional indexes assessed in the CV-PREVITAL Neuromed sub-study cohort
Time Frame: 12 months
Proportion of subjects who changed cognitive ability as measured by the Montreal cognitive assessment (MOCA) test, compared to the baseline.
12 months
Ancillary study of UO-6 (IRCCS Neuromed): Determinants of dietary changes in the CV-PREVITAL Neuromed sub-study cohort
Time Frame: 12 months
Multivariable analyses of determinants associated with dietary changes over 12 months follow-up period.
12 months
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline analysis of insulinemia in the CV-PREVITAL San Donato cohort
Time Frame: month 0
Baseline analysis of insulinemia (µU/ml) in the CV PREVITAL sub-study cohort and specifically in individuals with comorbidities such as diabetes mellitus, overweight, obesity, abdominal obesity.
month 0
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline analysis of Homocysteine in the CV-PREVITAL San Donato cohort
Time Frame: month 0
Baseline analysis of homocysteine (µmol/L) in the CV PREVITAL sub-study cohort and specifically in individuals with comorbidities such as diabetes mellitus, overweight, obesity, abdominal obesity.
month 0
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline analysis of CRP in the CV-PREVITAL San Donato cohort
Time Frame: month 0
Baseline analysis of CRP (mg/dl) in the CV PREVITAL sub-study cohort and specifically in individuals with comorbidities such as diabetes mellitus, overweight, obesity, abdominal obesity.
month 0
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline analysis of blood sodium and potassium levels in the CV-PREVITAL San Donato cohort
Time Frame: month 0
Baseline analysis of blood levels of sodium (mmol/L) and potassium (mmol/L) in the CV PREVITAL sub-study cohort and specifically in individuals with comorbidities such as diabetes mellitus, overweight, obesity, abdominal obesity.
month 0
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline analysis of sRAGE and IL-6 in the CV-PREVITAL San Donato cohort
Time Frame: month 0
Baseline analysis of blood levels of soluble receptor for advanced glycation end products (sRAGE) (pg/ml) and interleukin-6 (IL-6) (pg/ml) in the CV PREVITAL sub-study cohort and specifically in individuals with comorbidities such as diabetes mellitus, overweight, obesity, abdominal obesity.
month 0
Ancillary study of UO-7 (IRCCS Policlinico San Donato): 12-month change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) in the CV-PREVITAL San Donato cohort
Time Frame: 12 months
Changes compared to baseline of NT-proBNP (ng/L) in CV PREVITAL sub-study cohort including individuals with overweight, obesity, abdominal obesity.
12 months
Ancillary study of UO-7 (IRCCS Policlinico San Donato): 12-month change in thyroid stimulating hormone (TSH) in the CV-PREVITAL San Donato cohort
Time Frame: 12 months
Changes compared to baseline of TSH (µU/ml) in CV PREVITAL sub-study cohort including individuals with overweight, obesity, abdominal obesity.
12 months
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline relative wall thickness (ratio), E/A (ratio), and E/e' (ratio) as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
Time Frame: 7 years
Baseline left ventricular relative wall thickness (ratio), i.e. the ratio of end-diastolic radius to wall thickness, as detected by transthoracic-echocardiogram; baseline E/A (ratio), i.e. the ratio of peak velocity blood flow from left ventricular relaxation in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave), as detected by transthoracic-echocardiogram; baseline E/e' (ratio), i.e. the ratio of the peak early mitral inflow velocity (E) over the early diastolic mitral annular velocity (e'), as detected by transthoracic-echocardiogram.
7 years
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline Heart Mass (g) in the CV-PREVITAL San Donato cohort as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
Time Frame: 7 years
Transthoracic-echocardiogram detected baseline mass (g).
7 years
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline end-diastolic volume (ml), end-systolic volume (ml) and left atrial volume (ml) as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
Time Frame: 7 years
Transthoracic-echocardiogram detected baseline end-diastolic volume (ml), end-systolic volume (ml) and left atrial volume (ml).
7 years
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline Ejection Fraction (EF; %) in the CV-PREVITAL San Donato cohort as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
Time Frame: 7 years
Transthoracic-echocardiogram detected baseline Ejection Fraction (EF; %).
7 years
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline maximal tricuspid regurgitation velocity (TRV max) (m/s) in the CV-PREVITAL San Donato cohort as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
Time Frame: 7 years
Transthoracic-echocardiogram detected baseline TRV max (m/s).
7 years
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline epicardial adipose tissue (mm) in the CV-PREVITAL San Donato cohort as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
Time Frame: 7 years
Transthoracic-echocardiogram detected baseline epicardial adipose tissue (mm), identified as the echo-free space between the outer wall of the myocardium and the visceral layer of pericardium).
7 years
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline Carotid Artery Ultrasound imagining markers (IMT and plaques thickness) as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
Time Frame: 7 years
Baseline carotid arteries intimal-media thickness (IMT, mm) and plaque thickness (mm) measured with carotid artery ultrasound.
7 years
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline Carotid Artery Ultrasound imagining markers (Presence/absence of plaques) as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
Time Frame: 7 years
Presence/absence at baseline of carotid artery atherosclerotic plaques as detected by carotid artery ultrasound. An atherosclerotic lesion is considered plaque when its maximum thickness exceeds 1.5 mm.
7 years
Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline Carotid Artery Ultrasound imagining markers (total plaque area) as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
Time Frame: 7 years
Total baseline carotid plaque area (mm2). This variable is obtained by summing the areas of all atherosclerotic plaques visualized in the entire carotid tree by carotid ultrasound performed at baseline.
7 years
Ancillary study of UO-8 (Istituti Clinici Scientifici Maugeri IRCCS): Occurrence of cardiovascular events in the CV-PREVITAL MAUGERI sub-study cohort
Time Frame: 7 years
Occurrence of cardiovascular events over the 7-year follow-up period depending on the length of time in physical activities programs.
7 years
Ancillary study of UO-8 (Istituti Clinici Scientifici Maugeri IRCCS): Occurrence of new diagnosis of organ damage in the CV-PREVITAL MAUGERI sub-study cohort
Time Frame: 7 years
Occurrence new diagnosis of organ damage (silent ischemia) over the 7-year follow-up period depending on the length of time in physical activities programs.
7 years
Ancillary study of UO-8 (Istituti Clinici Scientifici Maugeri IRCCS): change in ankle brachial index (ABI) in the CV-PREVITAL MAUGERI sub-study cohort
Time Frame: 7 years
Change in ABI over the 7-year follow-up period depending on the length of time in physical activities programs.
7 years
Ancillary study of UO-8 (Istituti Clinici Scientifici Maugeri IRCCS): change in coronary calcium score in the CV-PREVITAL MAUGERI sub-study cohort
Time Frame: 7 years
Change in coronary calcium score as detected by CT scan over the 7-year follow-up period depending on the length of time in physical activities programs.
7 years
Ancillary study of UO-8 (Istituti Clinici Scientifici Maugeri IRCCS): change in markers of carotid damage in the CV-PREVITAL MAUGERI sub-study cohort
Time Frame: 7 years
Change from baseline in carotid arteries intimal-media thickness (IMT, mm) and plaque thickness (mm) as detected by carotid artery ultrasound over the 7-year follow-up period depending on the length of time in physical activities programs and the interaction of physical activity with other risk factors (e.g. obesity, hypertension, hypertriglyceridemia, etc.).
7 years
Ancillary study of UO-9 (ISMETT): 12-month change in coronary calcium score in the two arms in CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in CAC score (Coronary Artery Calcium score) as detected by CT scan in the two experimental groups. the CAC score is measured as described by Agatston, who defined CAC as the product of the calcified plaque area and maximal calcium lesion density. The lesion score is determined based on the maximal computed tomographic number in the following manner: 1= 130 to 199, 2= 200 to 299, 3 = 300 to 399, 4≥400 Hounsfield units. The latter means severe calcified plaque.
12 months
Ancillary study of UO-9 (ISMETT): 12-month change in myocardial fibrosis in the two arms in CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in myocardial fibrosis as detected by cardiac magnetic resonance in the two experimental groups. Outcome measure is the Delayed Enhancement (DE) left ventricular (LV) mass expressed as percentage of total LV Mass, and obtained through a Late Gadolinium Enhancement cardiac magnetic resonance. A DE-LV Mass > 10% is considered abnormal.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in biomarker of stress and heart failure in CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in circulating levels (mg/dL) of creatinine, blood urea, nitrogen (BUN) and high sensitivity C-Reactive Protein (HS-CRP) (mg/dL) in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in NT-proBN in CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in NT-proBN (pg/mL) in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in Na and K levels in CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in levels of Na and K (mmol/L) in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in homocysteine levels in CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in levels of homocysteine (micromol/L) in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in serum iron in CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in serum iron (microg/dL) in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in ferritin in CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in levels of ferritin (ng/mL) in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in transferrin in CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in levels of transferrin (g/L) in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): platelet and white blood cell count in the CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in the absolute number (x10^3 per microliter) of white blood cell (WBC), platelets, neutrophils, lymphocytes, monocytes, eosinophils, and basophils in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): red blood cell (RBC) count in the CV-PREVITAL ISMETT cohort
Time Frame: 12 months
Comparison of the mean change from baseline in the absolute number (x10^6 per microliter) of RBC in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): hemoglobin (Hb) in the CV-PREVITAL ISMETT sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in values of Hb (g/dL) in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): hematocrit (HCT) in the CV-PREVITAL ISMETT sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in values of HCT (%) in the two experimental groups.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): effect of specific cardiovascular risk factors on coronary calcium score in the CV PREVITAL ISMETT cohort
Time Frame: 12 months
Between group (usual-care and intervention) comparison of 12-months change in CAC score (Coronary Artery Calcium score) after stratification of the cohort according to specific cardiovascular risk factors (e.g. obesity, hypertension, diabetes etc). the CAC score is measured as described by Agatston, who defined CAC as the product of the calcified plaque area and maximal calcium lesion density. The lesion score is determined based on the maximal computed tomographic number in the following manner: 1= 130 to 199, 2= 200 to 299, 3 = 300 to 399, 4≥400 Hounsfield units. The latter means severe calcified plaque.
12 months
Ancillary study of UO-9 (IRCCS ISMETT): effect of specific cardiovascular risk factors on myocardial fibrosis in the CV PREVITAL ISMETT cohort
Time Frame: 12 months
Between group (usual-care and intervention) comparison of 12-months change in myocardial fibrosis as detected by cardiac magnetic resonance after stratification of the cohort according to specific cardiovascular risk factors (e.g. obesity, hypertension, diabetes etc).
12 months
Ancillary study of UO-9 (IRCCS ISMETT): effect of specific cardiovascular risk factors on biomarkers of stress and heart failure in the CV PREVITAL ISMETT cohort
Time Frame: 12 months
Between group (usual-care and intervention) comparison of 12-months change in circulating levels (mg/dL) of creatinine, blood urea and CRP (mg/dL) after stratification of the cohort according to specific cardiovascular risk factors (e.g. obesity, hypertension, diabetes etc).
12 months
Ancillary study of UO-10 (Ospedale Policlinico San Martino IRCCS): Prevalence of abdominal aortic aneurysms in the CV-PREVITAL San Martino sub-study cohort
Time Frame: month 0
Measurement of maximum diameter (mm) of abdominal aorta arteries by ultrasound in 1500 male subjects aged ≥ 45 years enrolled for primary prevention to identify eventual presence of aneurysms and estimate prevalence.
month 0
Ancillary study of UO-10 (Ospedale Policlinico San Martino IRCCS): Prevalence of iliac artery aneurysms in the CV-PREVITAL San Martino sub-study cohort
Time Frame: month 0
Measurement of maximum diameter (mm) of iliac arteries by ultrasound in 1500 male subjects aged ≥ 45 years enrolled for primary prevention to identify eventual presence of aneurysms and estimate prevalence.
month 0
Ancillary study of UO-10 (Ospedale Policlinico San Martino IRCCS): Prevalence of carotid artery stenosis in the CV-PREVITAL San Martino sub-study cohort.
Time Frame: month 0
Assessment of the prevalence of carotid artery stenosis in 500 male subjects aged ≥ 45 years enrolled for primary prevention.
month 0
Ancillary study of UO-10 (Ospedale Policlinico San Martino IRCCS): risk stratification for cardiovascular disease in the CV-PREVITAL San Martino sub-study cohort.
Time Frame: month 0
Measurement of the intima-media thickness of the supra-aortic trunks to increase the early identification of individuals prone to develop atherosclerosis and risk stratification for cardiovascular disease.
month 0
Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in markers of carotid damage (intimal-media thickness and plaques thickness) in the two arms in CV-PREVITAL blood donor sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in carotid arteries intimal-media thickness (IMT, mm) and plaque thickness (mm) as detected by carotid artery ultrasound in the two experimental groups.
12 months
Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in markers of carotid damage (Presence/absence of plaques) in the two arms in CV-PREVITAL blood donor sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in the prevalence of carotid artery atherosclerotic plaques as detected by carotid artery ultrasound in the two experimental groups. An atherosclerotic lesion is considered plaque when its maximum thickness exceeds 1.5 mm.
12 months
Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in Fibroscan CAP Score as a non-invasive biomarker of liver damage in the CV-PREVITAL blood donor sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in the amount of hepatic fat estimated non-invasively by using Fibroscan (CAP Score, dB/m) in the two experimental groups.
12 months
Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in Fibrosis-4 Index (FIB-4) as non-invasive biomarker of liver damage in the CV-PREVITAL blood donor sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in the hepatic fibrosis stage (FIB-4 Index) estimated non-invasively by using Fibroscan (Liver Stiffness Measurement - LSM, kPa) in the two experimental groups.
12 months
Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in circulating biomarker of lipotoxicity (Interleukin-32) in the CV-PREVITAL blood donor sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in interleukin-32 (IL-32, pg/mL) blood levels, as a biomarker of lipotoxicity in the two experimental groups.
12 months
Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in microalbuminuria in the CV-PREVITAL blood donor sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in microalbuminuria urine's levels as a biomarker of renal injury (mg/L) in the two experimental groups.
12 months
Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in enzymatic tests in the CV-PREVITAL blood donor sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in mean values (U/L) of aspartate aminotransferase (AST), alanine transaminase (ALT) and gamma-glutamyltransferase in the two experimental groups.
12 months
Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in insulinemia in the CV-PREVITAL blood donor sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in Insulinemia blood levels as biomarker of insulin resistance (microU/mL) in the two experimental groups.
12 months
Ancillary study of UO-11 (IRCCS Ca' Granda): characterization of the coagulation balance in the CV-PREVITAL blood donor sub-study cohort
Time Frame: month 0
Comparison of the baseline levels (%) of von Willebrand Factor Antigen, Protein C and Factor VIII in the two experimental groups.
month 0
Ancillary study of UO-11 (IRCCS Ca' Granda): D-Dimer levels in the CV-PREVITAL blood donor sub-study cohort
Time Frame: month 0
Comparison of baseline D-Dimer levels (ng/ml) in the two experimental groups.
month 0
Ancillary study of UO-11 (IRCCS Ca' Granda): 7-year change in taxonomic characterization of the intestinal microbiome in feces in a subsample of 200 participants
Time Frame: 7 years
Characterization of the intestinal microbiome in feces in a subsample of 200 participants by conducting a taxonomic analysis, with particular attention to Bacteroidetes/Firmicutes ratio.
7 years
Ancillary study of UO-11 (IRCCS Ca' Granda): 7-year change in characterization of the intestinal microbiome in feces in a subsample of 200 participants
Time Frame: 7 years
Characterization of the microbiome metagenomic functional profile in a subsample of 200 participants.
7 years
Ancillary study of UO-11 (IRCCS Ca' Granda): 7-year change in the intestinal microbiome in feces in a subsample of 200 participants (TMAO)
Time Frame: 7 years
Characterization of the intestinal microbiome in feces in a subsample of 200 participants by evaluation of TMAO serum levels.
7 years
Ancillary study of UO-11 (IRCCS Ca' Granda): 7-year change in characterization of the intestinal microbiome in feces in a subsample of 200 participants (branched-chain amino acid, BCAAs)
Time Frame: 7 years
Characterization of the intestinal microbiome in feces in a subsample of 200 participants by evaluation of branched-chain amino acid (BCAAs).
7 years
Ancillary study of UO-11 (IRCCS Ca' Granda): 7-year change in characterization of the intestinal microbiome in feces in a subsample of 200 participants (aromatic amino acid, AAAs)
Time Frame: 7 years
Characterization of the intestinal microbiome in feces in a subsample of 200 participants by evaluation of aromatic amino acid (AAAs).
7 years
Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in thickness of the medium-intimal complex of the common carotid in the CV-PREVITAL Inflammation and Microbiota sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in carotid imaging (Intimal- Media Thickness measured in plaque-free areas of common carotid arteries) in the two experimental groups.
12 months
Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in additional lipid parameters in the CV-PREVITAL-Inflammation and Microbiota sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in lipoprotein(a) and oxLDL values (ng/dL) in the two experimental groups.
12 months
Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in hs-CRP in the CV-PREVITAL Inflammation and Microbiota sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in hs-CRP (mg/L) in the two experimental groups.
12 months
Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in inflammatory mediators in the CV-PREVITAL-Inflammation and Microbiota sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline in plasma IL1beta, IL-18, IL-6, IL-10, TNF-alpha, and LPS values (pg/mL) in the two experimental groups.
12 months
Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in serum levels of trimethylamine oxide (TMAO) in the CV-PREVITAL Inflammation and Microbiota sub-study cohort
Time Frame: 12 months
Comparison of the mean change from baseline serum levels of TMAO (micromol/L) in the two experimental groups.
12 months
Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in intestinal microbiome composition and intestinal permeability in the CV-PREVITALInflammation and Microbiota sub-study cohort
Time Frame: 12 months
Change compared to baseline data of intestinal microbiome composition with Next Generation Sequencing (NGS) technology to identify alteration in the composition of the intestinal microbiome, both at a taxonomic and bacterial functional level. Change compared to baseline of zonulin serum level, a marker of intestinal permeability.
12 months
Ancillary study of UO-12 (IRCCS Gemelli):Long-term clinical outcome in the CV-PREVITAL Inflammation and Microbiota sub-study cohort
Time Frame: 7 years
Assessment of occurrence of cardiovascular events over the 7-year follow-up period, depending on the significant biomarkers variation and microbiome composition detected in the CV-PREVITAL Inflammation and Microbiota sub-study (OxLDL, TMAO, Zonulin, bacterial intestinal composition, etc.).
7 years
Ancillary study of UO-13 (IRCCS San Matteo): NGS multigene analysis for the early diagnosis of diabetes
Time Frame: 7 years
Prevalence of likely pathogenic and pathogenic variants classified according to ACMG criteria in genes related with diabetes in non-diabetic, pre-diabetic and diabetic subjects is analyzed by NGS panels of genes linked to monogenic diabetes in subjects of the San Matteo cohort and in subjects recruited by the IRCCS Monzino within the CV-PREVITAL PREDIABETES sub-study. DNA is collected from white blood cells. The gene prevalence is calculated as the ratio between patients carrying pathogenic variants and all patients of the studied cohort.
7 years
Ancillary study of UO-13 (IRCCS San Matteo): NGS multigene analysis for the diagnosis of familial dyslipidemia
Time Frame: 7 years
Prevalence of likely pathogenic and pathogenic variants classified according to ACMG criteria in genes related with familial hypercholesterolemia in subjects with diagnosis of hypercholesterolemia is analyzed by NGS panels of genes associated with familial hypercholesterolemia. The studied subjects are from the San Matteo cohort and from patients recruited by the IRCCS Monzino within the CV-PREVITAL PREDIABETES sub-study. DNA is collected from white blood cells.
7 years
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of physical activity in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in levels of physical activity as assessed by IPAQ (International Physical Activity Questionnaire) in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): amount of daily physical activity in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 3 months and 6 months
Change from baseline in the amount of daily physical activity measured through an accelerometer app in the two experimental groups.
3 months and 6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Mediterranean diet adherence by MDS questioner in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in adherence to Mediterranean diet as assessed by MDS (Mediterranean diet Scale)" questioner in the two experimental groups. The MDS scale may range from 0 to 55 and higher scores means higher Mediterranean diet adherence.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Mediterranean diet adherence by PREDIMED questioner in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in adherence to Mediterranean diet as assessed by PREDIMED (''Prevención con dieta mediterránea'') questioner in the two experimental groups. The PREDIMED score may range from 0 to 14 and higher scores means higher Mediterranean diet adherence.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Mediterranean diet adherence by Moli-Sani questioner in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in adherence to Mediterranean diet as assessed by the Moli-Sani study questioner in the two experimental groups. The Moli-Sani score may range from 0 to 21 and higher scores means higher Mediterranean diet adherence.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): salt intake in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in salt intake as assessed by MiniSal questionnaire in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of alcohol intake in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in alcohol intake as assessed by PREDIMED (''Prevención con dieta mediterránea'') questioner in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of stress (Perceived Stress Scale; PSS) in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in perceived stress as assessed by Perceived Stress Scale (PSS) in the two experimental groups. The PSS scale may range from 0 to 40 and higher values means higher perceived Stress.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of psychological distress (PHQ 4 questioner) in the CV-PREVITAL Exercise sub- study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in psychological distress as assessed by "Patient Health Questioner-4 (PHQ-4)" in the two experimental groups. The psychological distress PHQ-4 questioner may range from 0 to 12 and higher values means higher presence of the disorder.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of anxiety (PHQ 4 questioner) in the CV-PREVITAL Exercise sub- study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in anxiety as assessed by "Patient Health Questioner-4 (PHQ-4)" in the two experimental groups. The Anxiety PHQ-4 questioner may range from 0 to 6 and higher values means higher presence of the disorder.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of depression (PHQ 4 questioner) in the CV-PREVITAL Exercise sub- study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in depression as assessed by "Patient Health Questioner-4 (PHQ-4)" in the two experimental groups. The Depression PHQ-4 questioner may range from 0 to 6 and higher values means higher presence of the disorder.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of General Self Efficacy (GSE Scale) in the CV-PREVITAL Exercise sub- study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in general self-efficacy as assessed by "General Self Efficacy scale (GSE)" in the two experimental groups. The GSE scale may range from 10 to 40 and higher values mean greater self-efficacy perceived by the subject.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Multidimensional Health Locus of Control Scale (MHLCS) - Internality in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in locus of control as assessed by "Multidimensional Health Locus of Control Scale (MHLCS)-Internality" in the two experimental groups. The MHLCS-Internality may range from 6 to 36 and higher values means greater subject's internal locus of control.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Multidimensional Health Locus of Control Scale (MHLCS) - Powerful Others Externality in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in locus of control as assessed by "Multidimensional Health Locus of Control Scale (MHLCS)-powerful-others-externality" in the two experimental groups. The MHLCS-powerful-others-externality may range from 6 to 36 and higher values means greater subject's external (dependent on others) locus of control.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Multidimensional Health Locus of Control Scale (MHLCS) - Chance Externality in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in locus of control as assessed by "Multidimensional Health Locus of Control Scale (MHLCS)-chance-externality" in the two experimental groups. The MHLCS-chance-externality may range from 6 to 36 and higher values means greater external (case-dependent) locus of control of the subject.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Risk propensity in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in risk propensity as assessed by "Risk Propensity Scale (RPS)" in the two experimental groups. The RPS scale may range from 7 to 63 and higher values mean greater propensity to take risks.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of sleep quality in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in sleep quality as assessed by "Pittsburgh Sleep Quality Index (PSQI)" in the two experimental groups. The PSQI may range from 0 to 21 and higher values mean lower sleep quality.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of HDL-C, LDL-C, triglycerides and blood glucose in the CV- PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in fasting blood lipids and glucose levels (mg/dl) in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of HbA1c in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in HbA1c (%) in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): red blood cell (RBC) count in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in the absolute number (x10^6 per microliter) of RBC in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): platelet and white blood cell count in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in the absolute number (x10^3 per microliter) of white blood cell (WBC), platelets, neutrophils, lymphocytes, monocytes, eosinophils, and basophils in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): differential WBC count in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in the percent (%) of neutrophils, lymphocytes, monocytes, eosinophils, and basophils in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): hematocrit (HCT) and RBC Distribution Width (RDW) in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in values of HCT and RDW (%) in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): mean corpuscular volume (MCV) and mean platelet volume (MPV) in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in values of MCV and MPV (fL) in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): hemoglobin (Hb) and mean corpuscular hemoglobin concentration (MCHC) in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in values of Hb and MCHC (g/dL) in the two experimental groups.
6 months
Ancillary study of UO-14 (IRCCS San Raffaele Roma): mean corpuscular hemoglobin (MCH) in the CV-PREVITAL Exercise sub-study cohort
Time Frame: 6 months
Comparison of the mean change from baseline in values of MCH (pg) in the two experimental groups.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Cardiologico Monzino

Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IRCCS Policlinico S. Donato
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Istituto Auxologico Italiano
Istituto Di Ricerche Farmacologiche Mario Negri
Neuromed IRCCS
Istituti Clinici Scientifici Maugeri SpA
Humanitas Hospital, Italy
IRCCS Multimedica
Ospedale Policlinico San Martino
IRCCS San Raffaele Roma
Fondazione IRCCS Policlinico San Matteo di Pavia
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Investigators

  • Principal Investigator: Giulio Pompilio, Professor, Centro Cardiologico Monzino IRCCS
  • Principal Investigator: Gianfranco Parati, Professor, Istituto Auxologico Italiano IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2022

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R1256/20-CCM 1319
  • RCR-2019-23669116_001 (Other Grant/Funding Number: MINISTERO DELLA SALUTE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The IPD sharing plan is under definition

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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