Actively Recruiting

Phase Not Applicable
Age: 40Years - 69Years
All Genders
Healthy Volunteers
NCT05883878

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

Age: 40Years - 69Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • High cardiovascular risk based on SCORE 2 between 2.5% and 10%
  • Age between 40 and 69 years
Not Eligible

You will not qualify if you...

  • Diabetes
  • Familial hypercholesterolemia
  • Established cardiovascular disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dipartimento Universitario di Scienze della Vita e Sanità Pubblica

Roma, Italia, Italy, 00168

Actively Recruiting

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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

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