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.
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.
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
Single group
The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behavior
BehavioralBlood 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)
Change in the lifestyle profile
The lifestyle category will be measured using the Life's Essential 8 tool. A change will be considered achieved if there is a shift towards a more favorable lifestyle category at final follow-up at 6 months compared to baseline. The overall score ranges from 0 to 100, and the categories are three: * 0-49:Poor cardiovascular health * 50-79: Intermediate cardiovascular health * 80-100: Optimal cardiovascular health
Change in the LDL-Cholesterol
LDL-cholesterol (LDL-C) will be measured in mg/dL from fasting blood samples. The outcome will be defined as the change in LDL-C levels between baseline (enrollment) and final follow-up at 6 months.
Change in cardiovascular disease risk
The CVD risk of participants will be estimated using the SCORE2 (for individuals aged 40-69 years) and SCORE2-OP (for individuals aged ≥70 years) charts. A change will be defined as a shift towards a lower estimated risk at 6-month follow-up compared to baseline. The SCORE2 and SCORE2-OP classify individuals into four categories of 10-year risk of CVD events: * Low to moderate risk: \<5% (SCORE2, age 40-49), \<7.5% (age 50-69), \<10% (SCORE2-OP, age ≥70) * High risk: 5-10% (age 40-49), 7.5-15% (age 50-69), 10-20% (age ≥70) * Very high risk: \>10% (age 40-49), \>15% (age 50-69), \>20% (age ≥70)
Smoking habit modification
Number of participants who have quit or reduced smoking at the final follow-up at 6 months compared to baseline.
Change in Alcohol Consumption
Number of participants who have quit or reduced alcohol consumption at the final follow-up at 6 months compared to baseline.
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