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

Study acronym: CVRISK-IT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv3
  2. Minor Site details revised at 4 of 17 sitesv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06832644
Lead Sponsor IRCCS Policlinico S. Donato
Collaborators: Centro Cardiologico Monzino, Fondazione IRCCS Policlinico San Matteo di Pavia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Istituti Clinici Scientifici Maugeri SpA, Istituto Di Ricerche Farmacologiche Mario Negri, IRCCS Multimedica, Istituto Neurologico Mediterraneo Neuromed S. R. L, IRCCS San Raffaele, IRCCS San Raffaele Roma, IRCCS SYNLAB SDN, Istituto Clinico Humanitas, Istituto Nazionale di Ricovero e Cura per Anziani, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ospedale Policlinico San Martino, Istituto Auxologico Italiano
Conditions Cardiovascular Risk, Genetic Cardiovascular Risk
Enrollment 30,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov