Nuovi approcci di previsione del rischio per la prevenzione primaria delle malattie cardiovascolari in Italia: lo studio CVRisk-It (CVRisk-it) (CVRISK-IT)
Nuovi approcci di previsione del rischio per la prevenzione primaria delle malattie cardiovascolari in Italia: la prova CVRisk-It
The CVRISK-IT study aims to evaluate the health benefit of measuring genetic and imaging risk information in men and women considered at 'low-to-moderate' or 'high' risk of developing cardiovascular diseases (CVD) in a randomized controlled trial in Italian primary care settings. Our primary objective is to answer a fundamental question in the prevention and prediction of CVD in Italy and globally: is there any benefit in including additional information (such as genetic and/or imaging data) in estimating risk, in conjunction with lifestyle advice and medical treatment for primary prevention of CVD?
As a key secondary objective of the CVRISK-IT study, the goal is to build a large bioresource with clinical information and biological samples to facilitate a new generation of discovery and translational research that will advance understanding of the genetic, molecular and behavioural determinants as well as mechanisms of multiple chronic diseases in the Italian population. By contributing to the Rete Cardiologica database and the BBDCARDIO biobank, the CVRISK-IT study will also serve as a cornerstone for future investigations into the development and testing of early diagnostic technologies and preventive (or 'personalised precision health') interventions for chronic diseases.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
This multicenter, open randomized trial will investigate the effects of providing additional CVD risk information alongside personalised lifestyle advice and medical treatment in a primary prevention context across Italy. Healthy individuals aged 40 to 80 years, with no prior history of CVD or diabetes, will be recruited in two phases from the cohort of 17 participating IRCCS across Italy and affiliated enrolling centers. The population enrolled in this study consists of subjects who have never participated in other cardiovascular prevention studies of the Rete Cardiologica.
Phase 1 - Identification of the study population and development of the bioresource: various recruitment sources will be used, including institutions, primary care centres/services, government agencies, occupational health services, and volunteer organizations (e.g., blood donors). Participants will provide informed consent, a blood sample, and complete an electronic questionnaire. Approximately 30,000 individuals will be recruited and assessed using SCORE2/SCORE2-OP risk prediction models. Those identified as 'very high' risk will receive immediate medical treatment and will not proceed to phase 2.
Phase 2 - Randomization and novel risk prediction interventions: Participants identified as 'low-to-moderate' or 'high' CVD risk during phase 1 will be randomized, following a 2x2 factorial design into four groups within 1 week upon enrolment: a control group (no additional risk information), and three intervention groups (genetic, imaging-based and genetic + imaging-based risk information). The goal is to randomize around 12,000 participants in phase 2 (~3,000 per trial arm). All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The remaining 18,000 participants who won't proceed to phase 2 will still be involved in the study and contacted through a phone call follow-up with specialist at the 5◦ and 10◦ year.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ancona, Italia
- Reclutamento
- Irccs Inrca
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Contatto:
- Roberto Antonicelli, MD
- Numero di telefono: +390718003450
- Email: r.antonicelli@inrca.it
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Genova, Italia
- Non ancora reclutamento
- IRCCS San Martino
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Contatto:
- Pietro Ameri, MD
- Email: pietro.ameri@unige.it
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Milan, Italia
- Reclutamento
- IRCCS Ospedale San Raffaele
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Contatto:
- Paolo Camici, MD
- Numero di telefono: 02 2643 8190/8191
- Email: cvriskit@hsr.it
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Milan, Italia
- Reclutamento
- IRCCS Auxologico Italiano
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Contatto:
- Gianfranco Parati, MD
- Numero di telefono: 02-61911.1
- Email: gianfranco.parati@unimib.it
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Milan, Italia
- Reclutamento
- IRCCS Cardiologico Monzino
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Contatto:
- Damiano Baldassarre, MD
- Numero di telefono: +39 02.58002369
- Email: damiano.baldassarre@cardiologicomonzino.it
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Milan, Italia
- Non ancora reclutamento
- IRCCS Fondazione Cà Granda- Policlinico Milano
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Contatto:
- Stefano Carugo, MD
- Email: stefano.carugo@policlinico.mi.it
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Milan, Italia
- Non ancora reclutamento
- IRCCS Istituto Clinico Humanitas
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Contatto:
- Giuseppe Ferrante, MD
- Email: giuseppe.ferrante@hunimed.eu
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Milan, Italia
- Reclutamento
- IRCCS Mario Negri
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Contatto:
- Maria Carla Roncaglioni, MD
- Numero di telefono: 0239014-501
- Email: cvrisk-it_fase1@marionegri.it
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Milan, Italia
- Reclutamento
- IRCCS Multimedica
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Contatto:
- Francesco Bandera, MD
- Numero di telefono: 02.242091
- Email: francesco.bandera@multimedica.it
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Naples, Italia
- Non ancora reclutamento
- Irccs Synlab Sdn
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Contatto:
- Carlo Cavaliere, MD
- Email: carlo.cavaliere@synlab.it
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Palermo, Italia
- Non ancora reclutamento
- Irccs Ismett
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Contatto:
- Manlio Cipriani, MD
- Email: mcipriani@ismett.edu
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Pavia, Italia
- Non ancora reclutamento
- IRCCS Istituti Clinici Scientifici Maugeri
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Contatto:
- Maria Teresa La Rovere, MD
- Email: mariateresa.larovere@icsmaugeri.it
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Pavia, Italia
- Non ancora reclutamento
- IRCCS Fondazione Policlinico San Matteo
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Contatto:
- Eloisa Arbustini, MD
- Email: e.arbustini@smatteo.pv.it
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Pozzilli, Italia
- Non ancora reclutamento
- IRCCS Neuromed
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Contatto:
- Maria Benedetta Donati, MD
- Email: mariabenedetta.donati@neuromed.it
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Rome, Italia
- Non ancora reclutamento
- IRCCS Fondazione Policlinico Gemelli
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Contatto:
- Giovanna Liuzzo, MD
- Email: giovanna.liuzzo@policlinicogemelli.it
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Rome, Italia
- Non ancora reclutamento
- IRCCS San Raffaele Roma
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Contatto:
- Massimo Volpe, MD
- Email: massimo.volpe@sanraffaele.it
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San Donato Milanese, Italia
- Reclutamento
- IRCCS Policlinico San Donato
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Contatto:
- Chiara Barberio, PhD
- Numero di telefono: 02-52774838
- Email: cvriskit@grupposandonato.it
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Contatto:
- Ambra Cerri, PhD
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Investigatore principale:
- Lorenzo Menicanti, MD
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Sub-investigatore:
- Emanuele Diangelantonio, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age: 40-80 years
- Apparently healthy individuals without previous medical history of CVD or diabetes (based on medical diagnosis)
- Participant recruitment arranged only at selected IRCCS (and associated Spokes) as part of the 'Rete Cardiologica'
- Participants must have signed the Informed Consent and Data Privacy Treatment forms
- Participants must have a personal e-mail address and internet connection
Exclusion Criteria:
- Age ≤40 or ≥80 years
- Individuals have previous medical history related to CVD (e.g., heart failure, congenital heart disorder, coronary heart disease) based on medical diagnosis
- Candidates have previously participated in clinical studies of 'Rete Cardiologica' (e.g., PREVITAL)
- Medical diagnosis of mental disorders
- Pregnancy based on self-reported information
- Previous history of type 1 or type 2 diabetes (based on medical diagnosis)
- Oncology patients (based on physician indication)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Control
No additional cardiovascular risk information/recommendation is provided to the subject other than SCORE2/SCORE2-OP results of phase I. Thereby, the control group does not undergo neither imaging nor genetic analysis. |
|
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Sperimentale: Imaging
Subjects randomized in the imaging arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on imaging data analysis (i.e., carotid ultrasound or calcium score) |
All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The control group will also receive lifestyle advice along with medical treatment based only on their CVD risk provided at the baseline visit during phase I. |
|
Sperimentale: Polygenic Risk Score (PRS)
Subjects randomized in this arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on polygenic risk score (PRS) analysis obtained from blood samples collected at the baseline visit |
All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The control group will also receive lifestyle advice along with medical treatment based only on their CVD risk provided at the baseline visit during phase I. |
|
Sperimentale: Imaging and Polygenic Risk Score (PRS)
Subjects randomized in this arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on both imaging data (e.g., carotid ultrasound and/or calcium score) and genetic analysis (e.g., PRS). |
All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The control group will also receive lifestyle advice along with medical treatment based only on their CVD risk provided at the baseline visit during phase I. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in CVD risk using SCORE2/SCORE2-OP
Lasso di tempo: 12 months
|
The primary short-term outcome (i.e., 12 months after communication of the newly estimated CVD risk, following the randomisation step) is the change in CVD risk measured using SCORE2/SCORE2-OP risk prediction models. The CVD risk categories used to classify healthy people according to these scores are: 1) Low-to-moderate CVD risk: <50 years = <2.5 %; 50-69 years = <5%; ≥ 70 years = <7.5%. High CVD risk: <50 years = 2.5 to <7.5%; 50-69 years = 5 to <10%; ≥ 70 years 7.5 to <15%; Very high CVD risk: <50 years = ≥7.5%; 50-69 years = ≥10%; ≥ 70 years = ≥ 15%. |
12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in cardiovascular modifiable risk factors
Lasso di tempo: 12 months
|
Secondary short-term outcomes will include changes in objectively measured risk factors, such as cholesterol levels (i.e., total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) (mg/dl) |
12 months
|
|
Change in cardiovascular modifiable risk factors
Lasso di tempo: 12 months
|
Secondary short-term outcomes will include changes in objectively measured risk factors, such as blood pressure which will be measured 3 times in a row, and its average calculated (mmHg) |
12 months
|
|
Change in cardiovascular modifiable risk factors
Lasso di tempo: 12 months
|
Secondary short-term outcomes will include changes in objectively measured risk factors, such as smoking habits (e.g., switch from "usual smoker" to "not smoking anymore" categories) |
12 months
|
|
Change in CVD prevention-drugs prescription
Lasso di tempo: 12 months
|
Secondary short-term outcomes will include changes in CVD prevention-drugs prescription with respect to the baseline visit |
12 months
|
|
Evaluation of participant's adherence to ESC recommendations
Lasso di tempo: 12 months
|
By means of validated questionnaires, the assessment of participants' adherence to the lifestyle and dietary guidelines of the European Society of Cardiology (ESC) will be performed. If and where applicable, drugs prescription adherence will be evaluated as well as psychological outcomes |
12 months
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
CVD events recording in long-term period
Lasso di tempo: 5-10 years
|
The long-term outcomes will include the registration of CVD events in all enrolled participants in the long-term period (e.g., non-fatal myocardial infarction, acute coronary syndrome, percutaneous transluminal coronary angioplasty (PTCA), Coronary artery bypass grafting (CABG), non-fatal stroke), CVD mortality, and total mortality |
5-10 years
|
Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892.
- Di Angelantonio E, Piepoli M, Castelvecchio S, Barberio C, Chiarello C, Cerri A, Boveri S, Cardani R, Ambrogi F, Guelfi S, Baldassarre D, Colombo G, Amato M, Baetta R, Arbustini E, Liuzzo G, Kaptoge S, Severino A, Ferrante G, La Rovere MT, Parati G, Pengo MF, Latini R, Roncaglioni MC, Rigoni M, De Curtis A, Frati L, Ameri P, Camici PG, Volpe M, Menicanti L. Integrating genetic and imaging information to enhance cardiovascular risk stratification: rationale and design of the CVRISK-IT randomised controlled trial. Eur Heart J Qual Care Clin Outcomes. 2026 Mar 4:qcag032. doi: 10.1093/ehjqcco/qcag032. Online ahead of print.
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CVRISK-IT
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Informazioni su farmaci e dispositivi, documenti di studio
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