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.
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
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
Factorial
Lifestyle Management
BehavioralAll 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.
Change in CVD risk using SCORE2/SCORE2-OP
The primary short-term outcome (i.e., 12 months after communication of the newly estimated CVD risk, following the randomisation step) is the change in CVD risk measured using SCORE2/SCORE2-OP risk prediction models. The CVD risk categories used to classify healthy people according to these scores are: 1) Low-to-moderate CVD risk: \<50 years = \<2.5 %; 50-69 years = \<5%; ≥ 70 years = \<7.5%. High CVD risk: \<50 years = 2.5 to \<7.5%; 50-69 years = 5 to \<10%; ≥ 70 years 7.5 to \<15%; Very high CVD risk: \<50 years = ≥7.5%; 50-69 years = ≥10%; ≥ 70 years = ≥ 15%.
Change in cardiovascular modifiable risk factors
Secondary short-term outcomes will include changes in objectively measured risk factors, such as cholesterol levels (i.e., total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) (mg/dl)
Change in cardiovascular modifiable risk factors
Secondary short-term outcomes will include changes in objectively measured risk factors, such as blood pressure which will be measured 3 times in a row, and its average calculated (mmHg)
Change in cardiovascular modifiable risk factors
Secondary short-term outcomes will include changes in objectively measured risk factors, such as smoking habits (e.g., switch from "usual smoker" to "not smoking anymore" categories)
Change in CVD prevention-drugs prescription
Secondary short-term outcomes will include changes in CVD prevention-drugs prescription with respect to the baseline visit
CVD events recording in long-term period
The long-term outcomes will include the registration of CVD events in all enrolled participants in the long-term period (e.g., non-fatal myocardial infarction, acute coronary syndrome, percutaneous transluminal coronary angioplasty (PTCA), Coronary artery bypass grafting (CABG), non-fatal stroke), CVD mortality, and total mortality
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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
