Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
Healthy Volunteers
NCT06832644

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

Age: 40Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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