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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorIRCCS Policlinico S. Donato

About this trial

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.

Eligibility criteria

Qualifiers

Age: 40-80 years

Apparently healthy individuals without previous medical history of CVD or diabetes (based on medical diagnosis)

Participant recruitment arranged only at selected IRCCS (and associated Spokes) as part of the 'Rete Cardiologica'

Participants must have signed the Informed Consent and Data Privacy Treatment forms

Disqualifiers

Age ≤40 or ≥80 years

Individuals have previous medical history related to CVD (e.g., heart failure, congenital heart disorder, coronary heart disease) based on medical diagnosis

Candidates have previously participated in clinical studies of 'Rete Cardiologica' (e.g., PREVITAL)

Medical diagnosis of mental disorders

Trial design

Treatments tested in this trial

  • Lifestyle Management

Treatment groups

30,000 Participants
are divided into 4 treatment groups

Sponsors and collaborators

IRCCS Policlinico S. Donato

Lead sponsor

Centro Cardiologico Monzino

Collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

Collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborator

Istituti Clinici Scientifici Maugeri SpA

Collaborator

Istituto Di Ricerche Farmacologiche Mario Negri

Collaborator

IRCCS Multimedica

Collaborator

Istituto Neurologico Mediterraneo Neuromed S. R. L

Collaborator

IRCCS San Raffaele

Collaborator

IRCCS San Raffaele Roma

Collaborator

IRCCS SYNLAB SDN

Collaborator

Istituto Clinico Humanitas

Collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

Collaborator

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator

Ospedale Policlinico San Martino

Collaborator

Istituto Auxologico Italiano

Collaborator