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Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention
Sponsor: Catholic University of the Sacred Heart
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
Conditions
Interventions
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