Actively Recruiting
Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)
Led by IRCCS Policlinico S. Donato · Updated on 2026-01-14
30000
Participants Needed
17
Research Sites
257 weeks
Total Duration
On this page
Sponsors
I
IRCCS Policlinico S. Donato
Lead Sponsor
C
Centro Cardiologico Monzino
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 80 years
- Apparently healthy with no previous medical history of cardiovascular disease or diabetes
- Recruitment only at selected IRCCS and associated centers within the Rete Cardiologica
- Signed informed consent and data privacy forms
- Have a personal email address and internet access
You will not qualify if you...
- Age 40 years or younger, or older than 80 years
- Previous medical diagnosis of cardiovascular diseases such as heart failure, congenital heart disorder, or coronary heart disease
- Previous participation in Rete Cardiologica clinical studies
- Medical diagnosis of mental disorders
- Pregnancy (self-reported)
- Previous diagnosis of type 1 or type 2 diabetes
- Current oncology patients as indicated by a physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
IRCCS Cardiologico Monzino
Milan, Milan, Italy
Actively Recruiting
2
Irccs Inrca
Ancona, Italy
Not Yet Recruiting
3
IRCCS San Martino
Genova, Italy
Not Yet Recruiting
4
IRCCS Auxologico Italiano
Milan, Italy
Actively Recruiting
5
IRCCS Fondazione Cà Granda- Policlinico Milano
Milan, Italy
Not Yet Recruiting
6
IRCCS Istituto Clinico Humanitas
Milan, Italy
Not Yet Recruiting
7
IRCCS Mario Negri
Milan, Italy
Actively Recruiting
8
IRCCS Multimedica
Milan, Italy
Actively Recruiting
9
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
10
Irccs Synlab Sdn
Naples, Italy
Not Yet Recruiting
11
Irccs Ismett
Palermo, Italy
Not Yet Recruiting
12
IRCCS Fondazione Policlinico San Matteo
Pavia, Italy
Not Yet Recruiting
13
IRCCS Istituti Clinici Scientifici Maugeri
Pavia, Italy
Not Yet Recruiting
14
IRCCS Neuromed
Pozzilli, Italy
Not Yet Recruiting
15
IRCCS Fondazione Policlinico Gemelli
Rome, Italy
Not Yet Recruiting
16
IRCCS San Raffaele Roma
Rome, Italy
Not Yet Recruiting
17
IRCCS Policlinico San Donato
San Donato Milanese, Italy
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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