Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT06911294
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
69 Years
Study:
NCT06911294
Study Brief:
Protocol Section:
NCT06911294