NCT06888466 Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention

Trial Parameters

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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 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.

Eligibility Criteria

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

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