Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06832644
NA

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

Sponsor: IRCCS Policlinico S. Donato

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30000

Start Date

2025-01-22

Completion Date

2030-01-01

Last Updated

2026-01-14

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Lifestyle Management

All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The control group will also receive lifestyle advice along with medical treatment based only on their CVD risk provided at the baseline visit during phase I.

Locations (17)

IRCCS Cardiologico Monzino

Milan, Milan, Italy

Irccs Inrca

Ancona, Italy

IRCCS San Martino

Genova, Italy

IRCCS Auxologico Italiano

Milan, Italy

IRCCS Fondazione Cà Granda- Policlinico Milano

Milan, Italy

IRCCS Istituto Clinico Humanitas

Milan, Italy

IRCCS Mario Negri

Milan, Italy

IRCCS Multimedica

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Irccs Synlab Sdn

Naples, Italy

Irccs Ismett

Palermo, Italy

IRCCS Fondazione Policlinico San Matteo

Pavia, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, Italy

IRCCS Neuromed

Pozzilli, Italy

IRCCS Fondazione Policlinico Gemelli

Rome, Italy

IRCCS San Raffaele Roma

Rome, Italy

IRCCS Policlinico San Donato

San Donato Milanese, Italy