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Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)
Sponsor: IRCCS Policlinico S. Donato
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
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