The CVRISK-IT Trial in Italy Using Genetic and Imaging Information for Preventing Cardiovascular Diseases in Adults 40 to 80

What this Trial Is About

Researchers are investigating whether adding genetic and imaging information to standard cardiovascular risk assessments improves prevention and prediction of cardiovascular diseases CVD in adults aged 40 to 80 years without prior CVD or diabetes. This open, randomized trial takes place in Italian primary care settings and aims to build a large collection of clinical data and biological samples to support future research on chronic diseases and personalized health approaches. The study is conducted in two phases. In phase 1, about 30,000 participants are recruited and assessed using standard risk prediction tools those at very high risk receive immediate treatment and do not continue. In phase 2, approximately 12,000 participants identified as low-to-moderate or high risk are randomly assigned to one of four groups no additional risk information, genetic risk information, imaging risk information, or both genetic and imaging risk information. All participants receive personalized lifestyle advice and medical treatment based on their risk results. Participants provide blood samples and complete questionnaires, and their health is monitored for changes in cardiovascular risk and modifiable factors over 12 months. Follow-up calls are conducted at 5 and 10 years for those not proceeding to phase 2. The study measures changes in cardiovascular risk scores, medication use, and adherence to recommendations, aiming to improve prevention strategies for CVD.

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