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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT01030328
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-85
2. CAC 30-400, within 12 months of screening visit, OR intermediate stenosis on coronary artery CTA or invasive angiography (40-69% visual estimation) without the presence of obstructive (≥70% visual estimation) Stenosis within 3 months of screening visit
3. LDL-C ≥ 100 mg/dL and LDL-C ≤190 mg/dL at screening or baseline visit
4. TG\>150 mg/dL and TG/HDL\>3.5 at screening or baseline visit
5. 10 Year Framingham risk score of ≤ 10%
6. Ability and willingness to provide consent and Authorization for use of PHI
Exclusion Criteria:
1. Previous coronary revascularization (PCI, CABG)
2. Current lipid lowering therapy (includes statins, fibrates, niacin, omega 3 agents, intestinal cholesterol absorption inhibitors, cholestatic cholesterol absorption agents and other anti-lipemic agents.)
3. Known genetic form of hypercholesterolemia (e.g. familial hypercholesterolemia, etc.)
4. Creatinine 1.5 mg/dL or greater at baseline visit
5. Fasting serum triglycerides 500 mg/dL or greater at screening or baseline visit
6. Inability to perform CTA:
1. Arrhythmia precluding diagnostic CT examination
2. 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)
7. Uncontrolled hypertension (SBP\>180 mmHg or DBP\>130 mmHg on stable treatment)
8. Decompensated heart failure (NYHA class IV) at the time of enrollment
9. Known Pregnancy
10. Inability or unwillingness to consent and Authorization for use of PHI
11. Presence of any co-morbidity that makes life expectancy less than 24 months
12. Inability or unwillingness to comply with follow up procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01030328
Study Brief:
Protocol Section:
NCT01030328