RecruitingNot ApplicableNCT06832644

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

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


Sponsor

IRCCS Policlinico S. Donato

Enrollment

30,000 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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
  • Participants must have a personal e-mail address and internet connection

Exclusion Criteria7

  • 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
  • Pregnancy based on self-reported information
  • Previous history of type 1 or type 2 diabetes (based on medical diagnosis)
  • Oncology patients (based on physician indication)

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Interventions

BEHAVIORALLifestyle 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.


Locations(17)

IRCCS Cardiologico Monzino

Milan, Milan, Italy

Irccs Inrca

Ancona, Italy

IRCCS San Martino

Genova, Italy

IRCCS Auxologico Italiano

Milan, Italy

IRCCS Fondazione Cà Granda- Policlinico Milano

Milan, Italy

IRCCS Istituto Clinico Humanitas

Milan, Italy

IRCCS Mario Negri

Milan, Italy

IRCCS Multimedica

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Irccs Synlab Sdn

Naples, Italy

Irccs Ismett

Palermo, Italy

IRCCS Fondazione Policlinico San Matteo

Pavia, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, Italy

IRCCS Neuromed

Pozzilli, Italy

IRCCS Fondazione Policlinico Gemelli

Rome, Italy

IRCCS San Raffaele Roma

Rome, Italy

IRCCS Policlinico San Donato

San Donato Milanese, Italy

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NCT06832644


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