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
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