Status:

RECRUITING

Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention

Lead Sponsor:

Catholic University of the Sacred Heart

Conditions:

Cardiovascular Diseases

Eligibility:

All Genders

40+ years

Phase:

NA

Brief Summary

The goal of this clinical trial is to evaluate whether the disclosure of Polygenic Risk Scores (PRS) combined with personalized coaching on risk factors can lead to significant improvements in lifesty...

Detailed Description

This study aims to evaluate the efficacy of disclosing cardiovascular genetic risk-specifically through the Polygenic Risk Score (PRS)-in promoting the adoption of healthier lifestyle behaviors. The ...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Traditional cardiovascular risk: The risk will be assessed using SCORE 2 (low risk \< 2.5%, moderate risk between 2.5% and 5%, high risk between 5% and 10%) or SCORE 2-OP (moderate risk \< 7.5%, high risk between 7.5% and 15%).
  • Blood tests: Participants must have had blood tests performed within the past 6 months.
  • Age: Participants must be at least 40 years old.
  • Exclusion Criteria
  • Very high cardiovascular risk, as measured by SCORE 2 (very high risk \> 10%) or SCORE 2-OP (very high risk \> 15%).
  • Diabetes.
  • Familial hypercholesterolemia.
  • Previous cardiovascular events or established CVD

Exclusion

    Key Trial Info

    Start Date :

    June 1 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2026

    Estimated Enrollment :

    650 Patients enrolled

    Trial Details

    Trial ID

    NCT06888466

    Start Date

    June 1 2025

    End Date

    December 1 2026

    Last Update

    September 22 2025

    Active Locations (1)

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    Dipartimento Universitario di Scienze della Vita e Sanità Pubblica

    Roma, Italia, Italy, 00168