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Search / Trial NCT06911294

Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention

Launched by CATHOLIC UNIVERSITY OF THE SACRED HEART · Mar 28, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Coronary Artery Disease Polygenic Risk Score

ClinConnect Summary

This clinical trial is exploring new ways to help prevent heart disease, specifically coronary heart disease, by using personalized methods. Researchers want to see if using genetic testing (to understand a person's risk based on their genes) and health smartwatches (devices that track health data) can effectively motivate people to make healthier lifestyle choices. Participants will be assigned to one of four groups: standard care, genetic testing, a digital intervention with a wearable device, or a combination of both digital and genetic methods. The main goal is to find out if these methods are practical and if they help improve health.

To participate, you should be between 40 and 69 years old, have a moderate risk of heart disease, and meet certain health criteria related to conditions like obesity, high blood pressure, and cholesterol levels. Participants can expect to be part of a study that evaluates their experiences and the overall feasibility of these approaches in a real-world setting, like a doctor's office. This trial is currently recruiting participants of all genders, and it could be an exciting opportunity to help shape future heart disease prevention strategies.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 40-69 years;
  • 10 year cardiovascular risk score SCORE2 between 2.5% and 10%.
  • * Diagnosis of metabolic syndrome according to the American Heart Association criteria , defined as the presence of three or more of the following:
  • Central or abdominal obesity, measured by waist circumference (greater than 40 inches - 102 cm in men and 35 inches - 89 cm in women).
  • Elevated triglycerides: levels equal to or greater than 150 mg/dL or use of medication for hypertriglyceridemia.
  • Low HDL cholesterol levels (less than 40 mg/dL in men and less than 50 mg/dL in women) or use of cholesterol-lowering medication.
  • Elevated blood pressure: systolic ≥130 mmHg or diastolic ≥85 mmHg, or use of antihypertensive medication.
  • Elevated fasting blood glucose: ≥100 mg/dL or use of glucose-lowering medication.
  • Exclusion Criteria:
  • * Diabetes:
  • Familial hypercholesterolemia;
  • Previous cardiovascular events.

About Catholic University Of The Sacred Heart

The Catholic University of the Sacred Heart is a prestigious academic institution in Italy, renowned for its commitment to advancing medical research and education. With a strong emphasis on ethical standards and community well-being, the university actively engages in clinical trials that contribute to innovative healthcare solutions. Its multidisciplinary approach leverages expertise from various fields, fostering collaborations that enhance the quality and impact of research. The university is dedicated to improving patient outcomes through rigorous science and compassionate care, aligning with its mission to serve the greater good.

Locations

Rome, , Italy

Rome, , Italy

Rome, , Italy

Rome, , Italy

Rome, , Italy

Rome, , Italy

Rome, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported