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:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT00574457
Eligibility Criteria:
Inclusion Criteria:
* Informed written consent from the subject prior to testing.
* Age ≥40 years old with at least 1 of the following risk factors for coronary artery disease.
* cigarette smoking
* diabetes mellitus
* hypertension (systolic blood pressure ≥140 mm Hg or taking antihypertensive medication)
* hyperlipidemia (low-density lipoprotein cholesterol ≥130 mg/dl or high-density lipoprotein cholesterol less than 40 mg/dl)
* family history of CV disease in a male first-degree relative \<55 or a female first-degree relative \<65 years old
Exclusion Criteria:
* Age \>70 years
* Use of cholesterol-lowering medications in the past year
* Known active liver disease (AST or ALT \>2x upper limit of normal in home lab)
* Known active thyroid disease (TSH outside normal limits in home lab)
* Uncontrolled hypertension (blood pressure \>180/100 mmHg)
* Chronic kidney disease (on dialysis or known creatinine \>2.5 mg/dL)
* History of coronary artery disease (previous myocardial infarction, coronary revascularization procedure, angina pectoris with documented ischemia)
* History of cerebrovascular disease (previous stroke, transient ischemic attack, or carotid revascularization procedure)
* History of peripheral arterial disease (claudication with abnormal ankle-brachial indices or previous revascularization procedure)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00574457
Study Brief:
Protocol Section:
NCT00574457