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

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.

Conditions

• Cardiovascular Risk
• Genetic Cardiovascular Risk

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.

Sponsors & Collaborators

• Centro Cardiologico Monzino

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Istituti Clinici Scientifici Maugeri SpA

  collaborator OTHER

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• IRCCS Multimedica

  collaborator OTHER

• Istituto Neurologico Mediterraneo Neuromed S. R. L

  collaborator OTHER

• IRCCS San Raffaele

  collaborator OTHER

• IRCCS San Raffaele Roma

  collaborator OTHER

• IRCCS SYNLAB SDN

  collaborator OTHER

• Istituto Clinico Humanitas

  collaborator OTHER

• Istituto Nazionale di Ricovero e Cura per Anziani

  collaborator OTHER

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• Istituto Auxologico Italiano

  collaborator OTHER

• IRCCS Policlinico S. Donato

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-22

Primary Completion

2028-01-01

Completion

2030-01-01

Countries

• Italy

Study Locations