Actively Recruiting
Innovative Approaches for Personalised Cardiovascular Prevention
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-22
1020
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
Sponsors
F
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor
U
University Of Perugia
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to study innovative approaches for personalized primary preventive interventions for cardiovascular diseases (CVD) in the population. The main questions it aims to answer are: * efficacy and safety of the intervention * how to implement the interventions in the NHS Participants will be randomized in one of the four parallel arms: * standard of care; * genetic testing for cardiovascular genetic risk (through the cardiovascular Polygenic Risk Score or PRS); * digital intervention with a wearable device and its app; * digital intervention and genetic testing (PRS) The primary outcome we are going to evaluate is the efficacy of returning PRS information of CVD measured at baseline, alone or in combination with the use of a wearable device, on two endpoints: i) change in lifestyle pattern; ii) CVD risk profile modification. The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline, nor respect to subjects receiving traditional risk assessment plus adopting wearable devices.
CONDITIONS
Official Title
Innovative Approaches for Personalised Cardiovascular Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- High cardiovascular risk based on SCORE 2 between 2.5% and 10%
- Age between 40 and 69 years
You will not qualify if you...
- Diabetes
- Familial hypercholesterolemia
- Established cardiovascular disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
Roma, Italia, Italy, 00168
Actively Recruiting
Research Team
S
Stefania Boccia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here