Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)
NCT ID: NCT06832644
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30000 participants
INTERVENTIONAL
2025-01-22
2030-01-01
Brief Summary
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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.
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Detailed Description
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Phase 1 - Identification of the study population and development of the bioresource: various recruitment sources will be used, including institutions, primary care centres/services, government agencies, occupational health services, and volunteer organizations (e.g., blood donors). Participants will provide informed consent, a blood sample, and complete an electronic questionnaire. Approximately 30,000 individuals will be recruited and assessed using SCORE2/SCORE2-OP risk prediction models. Those identified as 'very high' risk will receive immediate medical treatment and will not proceed to phase 2.
Phase 2 - Randomization and novel risk prediction interventions: Participants identified as 'low-to-moderate' or 'high' CVD risk during phase 1 will be randomized, following a 2x2 factorial design into four groups within 1 week upon enrolment: a control group (no additional risk information), and three intervention groups (genetic, imaging-based and genetic + imaging-based risk information). The goal is to randomize around 12,000 participants in phase 2 (\~3,000 per trial arm). All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The remaining 18,000 participants who won't proceed to phase 2 will still be involved in the study and contacted through a phone call follow-up with specialist at the 5◦ and 10◦ year.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Control
No additional cardiovascular risk information/recommendation is provided to the subject other than SCORE2/SCORE2-OP results of phase I. Thereby, the control group does not undergo neither imaging nor genetic analysis.
No interventions assigned to this group
Imaging
Subjects randomized in the imaging arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on imaging data analysis (i.e., carotid ultrasound or calcium score)
Lifestyle 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.
Polygenic Risk Score (PRS)
Subjects randomized in this arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on polygenic risk score (PRS) analysis obtained from blood samples collected at the baseline visit
Lifestyle 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.
Imaging and Polygenic Risk Score (PRS)
Subjects randomized in this arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on both imaging data (e.g., carotid ultrasound and/or calcium score) and genetic analysis (e.g., PRS).
Lifestyle 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.
Interventions
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Lifestyle 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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
40 Years
80 Years
ALL
Yes
Sponsors
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Centro Cardiologico Monzino
OTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Istituti Clinici Scientifici Maugeri SpA
OTHER
Istituto Di Ricerche Farmacologiche Mario Negri
OTHER
IRCCS Multimedica
OTHER
Istituto Neurologico Mediterraneo Neuromed S. R. L
OTHER
IRCCS San Raffaele
OTHER
IRCCS San Raffaele Roma
OTHER
IRCCS SYNLAB SDN
OTHER
Istituto Clinico Humanitas
OTHER
Istituto Nazionale di Ricovero e Cura per Anziani
OTHER
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
OTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Ospedale Policlinico San Martino
OTHER
Istituto Auxologico Italiano
OTHER
IRCCS Policlinico S. Donato
OTHER
Responsible Party
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Lorenzo Menicanti
MD
Locations
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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
Countries
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Facility Contacts
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Roberto Antonicelli, MD
Role: primary
Ambra Cerri, PhD
Role: backup
References
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Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892.
Other Identifiers
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CVRISK-IT
Identifier Type: -
Identifier Source: org_study_id
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