European Society of Cardiology: cardiovascular disease statistics 2021.
Adam Timmis, Panos Vardas, Nick Townsend...
https://pubmed.ncbi.nlm.nih.gov/35016208Actively Recruiting
Phase Not Applicable
Age: 40Years - 80Years
All Genders
Healthy Volunteers
ID06832644
Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial
Led by IRCCS Policlinico S. Donato · Updated on 2026-01-14
30000
Participants Needed
17
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
IRCCS Policlinico S. Donato
Lead Sponsor
C
Centro Cardiologico Monzino
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether adding genetic and imaging information to standard cardiovascular risk assessments improves prevention and prediction of cardiovascular diseases (CVD) in adults aged 40 to 80 years without prior CVD or diabetes. This open, randomized trial takes place in Italian primary care settings and aims to build a large collection of clinical data and biological samples to support future research on chronic diseases and personalized health approaches. The study is conducted in two phases. In phase 1, about 30,000 participants are recruited and assessed using standard risk prediction tools; those at very high risk receive immediate treatment and do not continue. In phase 2, approximately 12,000 participants identified as low-to-moderate or high risk are randomly assigned to one of four groups: no additional risk information, genetic risk information, imaging risk information, or both genetic and imaging risk information. All participants receive personalized lifestyle advice and medical treatment based on their risk results. Participants provide blood samples and complete questionnaires, and their health is monitored for changes in cardiovascular risk and modifiable factors over 12 months. Follow-up calls are conducted at 5 and 10 years for those not proceeding to phase 2. The study measures changes in cardiovascular risk scores, medication use, and adherence to recommendations, aiming to improve prevention strategies for CVD.
CONDITIONS
Brief Title
Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)
Who Can Participate
Age: 40Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 40 and 80 years
- Apparently healthy individuals without previous history of cardiovascular disease or diabetes
- Recruitment only at selected IRCCS and associated centers in the Rete Cardiologica network
- Signed informed consent and data privacy forms
- Have a personal email address and internet access
You will not qualify if you...
- Age less than 40 or greater than 80 years
- Previous medical history of cardiovascular diseases such as heart failure, congenital heart disorder, or coronary heart disease
- Previous participation in Rete Cardiologica clinical studies
- Diagnosis of mental disorders
- Pregnancy
- Previous history of type 1 or type 2 diabetes
- Oncology patients as indicated by a physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Randomization and Intervention
Duration - 12 months
Participants identified as low-to-moderate or high cardiovascular disease risk are randomized into one of four groups to receive personalized lifestyle advice and medical treatment based on their assigned risk information.
1 baseline visit and periodic follow-up visits during 12 months
Long-term Monitoring
Duration - Up to 10 years
Participants not proceeding to randomization will be contacted by phone for follow-up at 5 and 10 years to monitor cardiovascular health.
2 phone call follow-ups
Trial Site Locations
Total: 17 locations
1
IRCCS Cardiologico Monzino
Milan, Milan, Italy
Actively Recruiting
2
Irccs Inrca
Ancona, Italy
Not Yet Recruiting
3
IRCCS San Martino
Genova, Italy
Not Yet Recruiting
4
IRCCS Auxologico Italiano
Milan, Italy
Actively Recruiting
5
IRCCS Fondazione Cà Granda- Policlinico Milano
Milan, Italy
Not Yet Recruiting
6
IRCCS Istituto Clinico Humanitas
Milan, Italy
Not Yet Recruiting
7
IRCCS Mario Negri
Milan, Italy
Actively Recruiting
8
IRCCS Multimedica
Milan, Italy
Actively Recruiting
9
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
10
Irccs Synlab Sdn
Naples, Italy
Not Yet Recruiting
11
Irccs Ismett
Palermo, Italy
Not Yet Recruiting
12
IRCCS Fondazione Policlinico San Matteo
Pavia, Italy
Not Yet Recruiting
13
IRCCS Istituti Clinici Scientifici Maugeri
Pavia, Italy
Not Yet Recruiting
14
IRCCS Neuromed
Pozzilli, Italy
Not Yet Recruiting
15
IRCCS Fondazione Policlinico Gemelli
Rome, Italy
Not Yet Recruiting
16
IRCCS San Raffaele Roma
Rome, Italy
Not Yet Recruiting
17
IRCCS Policlinico San Donato
San Donato Milanese, Italy
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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Published Research Related To This Trial
Integrating genetic and imaging information to enhance cardiovascular risk stratification: rationale and design of the CVRISK-IT randomised controlled trial.
Emanuele Di Angelantonio, Massimo Piepoli, Serenella Castelvecchio...
https://pubmed.ncbi.nlm.nih.gov/41778587