Innovative approaches for personalized cardiovascular prevention

Feasibility of InnovaTive Approaches for Personalized Cardiovascular PREVention: Randomized Controlled Pilot Trial and Multidisciplinary Evaluation for National Health Service Implementation

This study is testing if using genetic information and smartwatches can help people make healthier choices to prevent heart disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 40 Years to 69 Years
• Sex: All
• Sponsor: Catholic University of the Sacred Heart (other)
• Locations: 7 sites (Rome, Italy and 6 other locations)
• Trial ID: NCT06911294 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the feasibility of using innovative methods, such as Polygenic Risk Scores and health smartwatches, for personalized primary prevention of cardiovascular diseases. Participants will be randomized into four groups: standard care, genetic testing, digital intervention with a wearable device, or a combination of both. The study will assess the effectiveness of these interventions in promoting healthier lifestyle behaviors in a realistic setting, specifically within general practitioners' offices. The trial will last for 12 months, with key assessments at baseline, one month, six months, and twelve months.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-69 with a 10-year cardiovascular risk score between 2.5% and 10% and a diagnosis of metabolic syndrome.

Not a fit: Patients with diabetes, familial hypercholesterolemia, or a history of cardiovascular events may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective prevention strategies for coronary heart disease.

How similar studies have performed: Other studies have shown promise in using genetic risk scores and digital interventions for cardiovascular prevention, indicating a potential for success in this approach.

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.

Where this trial is running

Rome, Italy and 6 other locations

• Studio Antonaci — Rome, Italy, Italy (RECRUITING)
• Studio Colletti — Rome, Italy (RECRUITING)
• Studio Maggiori — Rome, Italy (RECRUITING)
• Studio Mammucari — Rome, Italy (RECRUITING)
• Studio Marra — Rome, Italy (RECRUITING)
• Studio Paoletti — Rome, Italy (RECRUITING)
• Studio Pasca — Rome, Italy (RECRUITING)

Study contacts

• Study coordinator: Roberta Pastorino

Conditions: Coronary Heart Disease, coronary artery disease, Polygenic Risk Score