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

NCT06832644 | Recruiting DMC

• 1 other identifier: CVRISK-IT
• Study Type: interventional
• Target: 30,000
• Locations: 1 country
• Sites: 17

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.

Conditions

Cardiovascular Risk; Genetic Cardiovascular Risk

Keywords

Primary Prevention; Cardiovascular Risk; SCORE2/2-OP

Outcome Measures

Primary Outcomes (1)

• 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%.

  12 months

Secondary Outcomes (5)

• Change in cardiovascular modifiable risk factors

  12 months

• Change in cardiovascular modifiable risk factors

  12 months

• Change in cardiovascular modifiable risk factors

  12 months

• Change in CVD prevention-drugs prescription

  12 months

• Evaluation of participant's adherence to ESC recommendations

  12 months

Other Outcomes (1)

• CVD events recording in long-term period

  5-10 years

Study Arms (4)

Control

NO INTERVENTION

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.

Imaging

EXPERIMENTAL

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)

Behavioral: Lifestyle Management

Polygenic Risk Score (PRS)

EXPERIMENTAL

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

Behavioral: Lifestyle Management

Imaging and Polygenic Risk Score (PRS)

EXPERIMENTAL

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).

Behavioral: Lifestyle Management

Interventions

Lifestyle Management BEHAVIORAL

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; Imaging and Polygenic Risk Score (PRS); Polygenic Risk Score (PRS)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: collaborator
• IRCCS Policlinico S. Donato: lead
• 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
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Ospedale Policlinico San Martino: collaborator
• Istituto Auxologico Italiano: collaborator
• Centro Cardiologico Monzino: collaborator

Study Sites (17)

IRCCS Cardiologico Monzino

Milan, Milan, Italy

RECRUITING

Irccs Inrca

Ancona, Italy

NOT YET RECRUITING

IRCCS San Martino

Genova, Italy

NOT YET RECRUITING

IRCCS Auxologico Italiano

Milan, Italy

RECRUITING

IRCCS Fondazione Cà Granda- Policlinico Milano

Milan, Italy

NOT YET RECRUITING

IRCCS Istituto Clinico Humanitas

Milan, Italy

NOT YET RECRUITING

IRCCS Mario Negri

Milan, Italy

RECRUITING

IRCCS Multimedica

Milan, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

Irccs Synlab Sdn

Naples, Italy

NOT YET RECRUITING

Irccs Ismett

Palermo, Italy

NOT YET RECRUITING

IRCCS Fondazione Policlinico San Matteo

Pavia, Italy

NOT YET RECRUITING

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, Italy

NOT YET RECRUITING

IRCCS Neuromed

Pozzilli, Italy

NOT YET RECRUITING

IRCCS Fondazione Policlinico Gemelli

Rome, Italy

NOT YET RECRUITING

IRCCS San Raffaele Roma

Rome, Italy

NOT YET RECRUITING

IRCCS Policlinico San Donato

San Donato Milanese, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 35016208 BACKGROUND

• Di Angelantonio E, Piepoli M, Castelvecchio S, Barberio C, Chiarello C, Cerri A, Boveri S, Cardani R, Ambrogi F, Guelfi S, Baldassarre D, Colombo G, Amato M, Baetta R, Arbustini E, Liuzzo G, Kaptoge S, Severino A, Ferrante G, La Rovere MT, Parati G, Pengo MF, Latini R, Roncaglioni MC, Rigoni M, De Curtis A, Frati L, Ameri P, Camici PG, Volpe M, Menicanti L. Integrating genetic and imaging information to enhance cardiovascular risk stratification: rationale and design of the CVRISK-IT randomised controlled trial. Eur Heart J Qual Care Clin Outcomes. 2026 Mar 4:qcag032. doi: 10.1093/ehjqcco/qcag032. Online ahead of print.

  PMID: 41778587 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 18, 2025
• Study Start: January 22, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

IT (17)