Evaluating new methods for predicting cardiovascular disease risk in Italy
Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial
This study is testing whether using genetic and imaging information can help people in Italy understand their risk of heart disease better and improve their health through tailored advice and treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30000 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 17 sites (Milan, Milan and 16 other locations) |
| Trial ID | NCT06832644 on ClinicalTrials.gov |
What this trial studies
The CVRISK-IT study investigates the health benefits of incorporating genetic and imaging risk information for individuals at low-to-moderate or high risk of cardiovascular diseases (CVD) in Italy. This multicenter, open randomized trial will recruit healthy participants aged 40 to 80 years from various primary care settings and assess their risk using SCORE2/SCORE2-OP models. Those identified as low-to-moderate or high risk will be randomized into groups receiving different levels of risk information alongside lifestyle advice and medical treatment. The study also aims to create a bioresource for future research on chronic diseases in the Italian population.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 40 to 80 years with no prior history of cardiovascular disease or diabetes.
Not a fit: Patients with a history of cardiovascular disease, diabetes, or those outside the age range of 40 to 80 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of cardiovascular disease risk prediction and improve preventive strategies for patients.
How similar studies have performed: Other studies have shown promise in using genetic and imaging data for risk prediction, but this specific approach is novel in the Italian context.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Milan, Milan and 16 other locations
- IRCCS Cardiologico Monzino — Milan, Milan, Italy (Recruiting)
- Irccs Inrca — Ancona, Italy (Not_yet_recruiting)
- IRCCS San Martino — Genova, Italy (Not_yet_recruiting)
- IRCCS Auxologico Italiano — Milan, Italy (Recruiting)
- IRCCS Fondazione Cà Granda- Policlinico Milano — Milan, Italy (Not_yet_recruiting)
- IRCCS Istituto Clinico Humanitas — Milan, Italy (Not_yet_recruiting)
- IRCCS Mario Negri — Milan, Italy (Recruiting)
- IRCCS Multimedica — Milan, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
- Irccs Synlab Sdn — Naples, Italy (Not_yet_recruiting)
- Irccs Ismett — Palermo, Italy (Not_yet_recruiting)
- IRCCS Fondazione Policlinico San Matteo — Pavia, Italy (Not_yet_recruiting)
- IRCCS Istituti Clinici Scientifici Maugeri — Pavia, Italy (Not_yet_recruiting)
- IRCCS Neuromed — Pozzilli, Italy (Not_yet_recruiting)
- IRCCS Fondazione Policlinico Gemelli — Rome, Italy (Not_yet_recruiting)
- IRCCS San Raffaele Roma — Rome, Italy (Not_yet_recruiting)
- IRCCS Policlinico San Donato — San Donato Milanese, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.