Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)

Recruiting now · Not applicable

Conditions studied: Cardiovascular Risk, Genetic Cardiovascular Risk

In brief

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.

Key facts

Study ID

NCT06832644

Run by

IRCCS Policlinico S. Donato

People needed

30000

Starts

2025-01-22

Expected to finish

2030-01-01

Last updated by the study team

2026-01-14

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• IRCCS Policlinico San Donato — San Donato Milanese, Italy (enrolling)
• IRCCS Auxologico Italiano — Milan, Italy (enrolling)
• IRCCS Mario Negri — Milan, Italy (enrolling)
• IRCCS Multimedica — Milan, Italy (enrolling)
• IRCCS Ospedale San Raffaele — Milan, Italy (enrolling)
• IRCCS Cardiologico Monzino — Milan, Milan, Italy (enrolling)
• IRCCS Neuromed — Pozzilli, Italy
• IRCCS Fondazione Policlinico Gemelli — Rome, Italy
• IRCCS San Raffaele Roma — Rome, Italy
• Irccs Synlab Sdn — Naples, Italy
• Irccs Ismett — Palermo, Italy
• IRCCS Fondazione Policlinico San Matteo — Pavia, Italy
• Irccs Inrca — Ancona, Italy
• IRCCS San Martino — Genova, Italy
• IRCCS Istituti Clinici Scientifici Maugeri — Pavia, Italy
• IRCCS Fondazione Cà Granda- Policlinico Milano — Milan, Italy
• IRCCS Istituto Clinico Humanitas — Milan, Italy

Full record on ClinicalTrials.gov

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