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RECRUITING
NCT06888466
NA

Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention

Sponsor: Catholic University of the Sacred Heart

View on ClinicalTrials.gov

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 lifestyle behaviors among staff members at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The study includes staff members from Fondazione Policlinico Universitario Agostino Gemelli IRCCS, enrolled at the outpatient clinics of the Cardiology Department. Main Research Questions: 1. Does receiving PRS disclosure and personalized coaching lead to significant improvements in lifestyle behaviors compared to baseline measurements? 2. How do different levels of genetic predisposition to cardiovascular diseases (CVD) impact behavioral changes following intervention? This is a single arm, pre-post clinical trial. Participant will: * Undergo genetic testing to assess their Polygenic Risk Score for CVDs * receive personalized, in-person consultation with a medical cardiologis, together with and individualized recommendations for CVD prevention based on PRS results and traditional risk factors.

Official title: Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention and Behavioral Change

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

650

Start Date

2025-06-01

Completion Date

2026-12

Last Updated

2026-02-20

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behavior

Blood samples collected for the calculation of the genetic predisposition profile for Cardiovascular risk will be used for DNA extraction and genotyping, and the PRS will subsequently be calculated. Based on the results, individuals will be classified into three main CVD risk categories (high risk, intermediate risk, low risk)

Locations (1)

Dipartimento Universitario di Scienze della Vita e Sanità Pubblica

Roma, Italia, Italy