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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT00862056
Eligibility Criteria:
Inclusion Criteria:
* Males between ages 35-90 or females between ages 40-90
* No known coronary artery disease
* no prior coronary disease by cardiac catheterization (no more than 40% in any major epicardial vessel)
* no prior myocardial infarction
* no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous leads)
* no prior non-ST-elevation myocardial infarction (CK-MB \> 2x ULN or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints)
* no prior coronary revascularization procedure
* Aymptomatic
* no chest pain, shortness of breath, angina or angina-equivalent that is assumed to be related to myocardial ischemia
* Presence of a high-risk feature (at least one of the following four will quality)
* High FRS ≥20% (http://hp2010.nhlbihin.net/atpiii/calculator.asp)
* Diabetes Mellitus
* Premature CAD in a first-degree relative
* High Risk Lipid Profile (must meet one of the following laboratory criteria)
1. LDL \> 250 mg/dL
2. HDL \< 20 mg/dL
3. Triglycerides \> 1000 mg/dL
4. LP(a) \> 80 mg/dL
* Provide written informed consent and Authorization for Use/Disclosure of PHI
Exclusion Criteria:
* Known genetic form of hypercholesterolemia based on clinical criteria (e.g. familial hypercholesterolemia, etc.)
* Creatinine 1.5 mg/dL or greater
* Irregular rhythm precluding cardiac CT examination
* Uncontrolled hypertension (SBP\>210 mmHg or DBP\>140 mmHg on treatment)
* Known moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion)
* Known Pregnancy
* Unwilling or unable to consent
* Presence of any co-morbidity that makes life expectancy less than 24 months
* Unwilling or unable to complete follow-up
* Unwilling or unable to provide written informed consent and Authorization for Use/Disclosure of PHI
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
90 Years
Study:
NCT00862056
Study Brief:
Protocol Section:
NCT00862056