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Innovative Approaches for Personalised Cardiovascular Prevention

NCT05883878 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1020

Last updated 2025-08-22

No results posted yet for this study

Summary

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

Interventions

GENETIC

PRS

genetic test for the evaluation of PRS cardiovascular risk

DEVICE

Digital app and wearable device

a wearable device connected with its app

Sponsors & Collaborators

  • University Of Perugia

    collaborator OTHER

  • Policlinic Hospital "G. Rodolico"

    collaborator OTHER

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2025-11-30
Completion
2026-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05883878 on ClinicalTrials.gov