Innovative approaches for personalized cardiovascular prevention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Roberta Pastorino
• Email: roberta.pastorino@unicatt.it
• Phone: +393495624174

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.