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:
NCT04551456
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years at Visit 1;
2. Patient must provide written informed consent;
3. Have a diagnosis of coronary artery atherosclerotic disease as defined by any of the following 3 criteria:
1. Previous MI is documented by a clinical history or documented either by hospital records or by evidence that includes an elevation of cardiac enzymes and/or electrocardiogram (ECG) changes consistent with MI.
2. All patients underwent invasive coronary angiography at the time of presentation and were revascularized if clinically indicated, or these patients underwent coronary CTA
3. Multivessel coronary disease confirmed by coronary angiography or CTA
Exclusion Criteria:
1. Evidence of a life-threatening arrhythmia (ventricular tachycardia or complete heart block) on screening ECG..
2. Have a hematologic abnormality as evidenced by hematocrit \<25% , white blood cell \<2500/u L or platelet values\<100000/u L without another explanation.
3. Have liver dysfunction, as evidenced by enzymes (aspartate aminotransferase and alanine aminotransferase) \>3× the upper limits of normal.
4. Have a coagulopathy (international normalized ratio\>1.3) not because of a reversible cause (ie, coumadin).
5. Be an organ transplant recipient.
6. Have a clinical history of malignancy within 5 y except curatively treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
7. Have a noncardiac condition that limits lifespan to \<1y.
8. Have a history of drug or alcohol abuse within the past 24 m.
9. Be serum positive for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C.
10. Be a female who is pregnant, nursing, or of childbearing potential who is not practicing effective contraceptive methods.-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04551456
Study Brief:
Protocol Section:
NCT04551456