Clinical trial NCT06832644: Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)
Official title: Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Risk
Genetic Cardiovascular Risk
Keywords: Primary Prevention
Cardiovascular Risk
SCORE2/2-OP
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: Centro Cardiologico Monzino
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Istituti Clinici Scientifici Maugeri SpA
name: Istituto Di Ricerche Farmacologiche Mario Negri
name: IRCCS Multimedica
name: Istituto Neurologico Mediterraneo Neuromed S. R. L
name: IRCCS San Raffaele
name: IRCCS San Raffaele Roma
name: IRCCS SYNLAB SDN
name: Istituto Clinico Humanitas
name: Istituto Nazionale di Ricovero e Cura per Anziani
name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Ospedale Policlinico San Martino
name: Istituto Auxologico Italiano
First posted: 2025-02-18
Enrollment: 30000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This multicenter, open randomized trial will investigate the effects of providing additional CVD risk information alongside personalised lifestyle advice and medical treatment in a primary prevention context across Italy. Healthy individuals aged 40 to 80 years, with no prior history of CVD or diabetes, will be recruited in two phases from the cohort of 17 participating IRCCS across Italy and affiliated enrolling centers. The population enrolled in this study consists of subjects who have never participated in other cardiovascular prevention studies of the Rete Cardiologica.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Change in CVD risk using SCORE2/SCORE2-OP
timeFrame: 12 months
Secondary outcomes:
measure: Change in cardiovascular modifiable risk factors
timeFrame: 12 months
measure: Change in cardiovascular modifiable risk factors
timeFrame: 12 months
measure: Change in cardiovascular modifiable risk factors
timeFrame: 12 months
measure: Change in CVD prevention-drugs prescription
timeFrame: 12 months
measure: Evaluation of participant's adherence to ESC recommendations
timeFrame: 12 months
Other outcomes:
measure: CVD events recording in long-term period
timeFrame: 5-10 years
Locations:
city: Ancona
country: Italy
facility: Irccs Inrca
city: Genova
country: Italy
facility: IRCCS San Martino
city: Milan
country: Italy
facility: IRCCS Auxologico Italiano
city: Milan
country: Italy
facility: IRCCS Cardiologico Monzino
city: Milan
country: Italy
facility: IRCCS Fondazione Cà Granda- Policlinico Milano
city: Milan
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Milan
country: Italy
facility: IRCCS Mario Negri
city: Milan
country: Italy
facility: IRCCS Multimedica
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Naples
country: Italy
facility: Irccs Synlab Sdn
city: Palermo
country: Italy
facility: Irccs Ismett
city: Pavia
country: Italy
facility: IRCCS Fondazione Policlinico San Matteo
city: Pavia
country: Italy
facility: IRCCS Istituti Clinici Scientifici Maugeri
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
city: Rome
country: Italy
facility: IRCCS Fondazione Policlinico Gemelli
city: Rome
country: Italy
facility: IRCCS San Raffaele Roma
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
Study officials:
References:
citation: 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.