Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention

NCT06888466 | Recruiting

• 1 other identifier: 6732
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular prevention; Polygenic Risk Score

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the final follow-up at 6 months.

Secondary Outcomes (11)

• Change in the LDL-Cholesterol

  From enrollmentto the final follow-up at 6 months

• Change in cardiovascular disease risk

  From enrollment to the final follow-up at 6 months.

• Smoking habit modification

  From enrollment to the final follow-up at 6 months.

• Change in Alcohol Consumption

  From enrollment to the final follow-up at 6 months.

• Anxiety

  Measured at enrollment and again one month after receiving PRS results.

Study Arms (1)

PRS

EXPERIMENTAL

Lifestyle coaching and genetic intervention: calculation of the Polygenic Risk Score (PRS)

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

Interventions

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

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)

PRS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Dipartimento Universitario di Scienze della Vita e Sanità Pubblica

Roma, Italia, 00168, Italy

RECRUITING

Related Links

• EU Health Policy
• PNRR - Governo Italiano Presidenza del Consiglio dei Ministri
• Next Generation Italia, approvato il piano del Governo - Next Generation Italia, approvato il piano del Governo
• Personalised Medicine - European Commision

MeSH Terms

Conditions

Cardiovascular Diseases; Genetic Risk Score

Condition Hierarchy (Ancestors)

Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stefania Boccia

CONTACT

+39 0630154396; stefania.boccia@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Hygiene and Preventive Medicine

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 21, 2025
• Study Start: June 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)