Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Italy / NCT06888466
Recruiting Not applicable

Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention

NCT06888466 · tracked via the Priya Life Science Italy tracker
Sponsor
Catholic University of the Sacred Heart
Phase
Not applicable
Started
2025-06-01
Last updated
2026-02-20

Condition(s) studied

Cardiovascular Diseases

Investigational drug(s) / intervention(s)

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

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)

Study 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

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change in the lifestyle profile — From enrollment to the final follow-up at 6 months.
    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

Trial sites (1)

FacilityCityRegionStatus
Dipartimento Universitario di Scienze della Vita e Sanità Pubblica Roma Italia Recruiting

More Catholic University of the Sacred Heart trials in Italy

Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery Starting soon
Microbiome-based Diagnostic Tool for the Screening of Colorectal Cancer (GUILTI) Recruiting
Study for the Identification of a Score to Assess Intrapancreatic Fat Through Eco-Elastography and Its Correlation With Metabolic Syndrome and Insulin-Secreting Cells. Recruiting
Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction: the PROVE Study Recruiting
Effects of a Placebo Probiotic on Gut Health and General Well-being in Individuals With Mild Gastrointestinal Symptoms Recruiting

Other trials for the same condition

New Technological Pathway for Gait Rehabilitation Starting soon
Study of the Characteristics of the Vascular Wall in Pediatric Age Recruiting
Multicenter Evaluation of Patients Using LATITUDE Monitoring System Recruiting
Integrating Exercise Into Lifestyle of Cardiac Outpatients Recruiting
AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06888466 on ClinicalTrials.gov ↗ ← All trials in Italy