The Cardiovascular Prevention Program

August 27, 2024 updated by: Maria Cecilia Hospital

Cardiovascular Prevention Program at Maria Cecilia Hospital

Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. In Europe, mortality per year is equal to 2.2 million women and 1.9 million men, representing 47% and 37% of all deaths respectively. In Italy, the situation in terms of deaths due to cardiovascular diseases it is in line with the world ranking and European, being responsible for 44% of all deaths. The only interventional or pharmacological approach is neither effective nor sustainable. The most deaths from cardiovascular diseases are due to atherothrombotic events, which are attributable to a series of risk factors, most of which are modifiable. Turns out itself as a targeted action on these factors with the aim of safeguarding the state of health cardiovascular, may represent the best applicable strategy. It is therefore necessary structure and activate prevention programs aimed at the general population and groups of subjects at higher risk.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

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 Locations

  • Italy
    • Ravenna
      • Cotignola, Ravenna, Italy, 48033
        • Recruiting
        • MCH
        • Contact:
          • Anna Maria Malagoni

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • primary prevention: age ≥ 30 years with a negative history of cardiovascular events
  • secondary prevention: age ≥ 30 years with a negative history of cardiovascular events

Exclusion Criteria:

  • severe obesity
  • high-grade renal failure
  • severe and/or dialysis
  • oncological disease in active phase
  • pregnancy

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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: subject with a negative or positive history of cardiovascular disease
no drugs or devices are included.
Other: International Physical Activity Questionnaire
Assessments of physical activity level and functional capabilities (aerobic capacity, muscular strength and power, flexibility
Other: Six minute walking test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Other: SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21.
Evaluation of the quality of life, the psychological sphere (anxiety, stress, depression) and the quality of sleep
Other: MEDAS
Evaluation of adherence to the Mediterranean diet
Other: Intima-media thickness (IMT)
Bmode ultrasonography
Biological: Blood sampling
Measurement of parameters for defining cardiovascular risk and biomarkers.
Biological: Stool Sample Culture Test
Evaluation of Gut Microbiota

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure of body mass index
Time Frame: 12 months
BMI Assessment
12 months
Adherence to the Mediterranean diet
Time Frame: 12 months
Mediterranean Diet Adherence
12 months
blood test to check cholesterol levels
Time Frame: 12 months
Assessment of hypercholesterolemia
12 months
blood pressure measurement
Time Frame: 12 months
Evaluation of Diastolic Blood Pressure
12 months
blood glucose test
Time Frame: 12 months
evaluation of blood glucose
12 months

Collaborators and Investigators

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

Sponsor

Maria Cecilia Hospital

Investigators

  • Principal Investigator: Anna Maria Malagoni, Maria Cecilia Hospital

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)

May 13, 2024

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MCH-ProCardioPrev

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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