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 @ 4:47 AM
Ignite Modification Date:
2025-12-25 @ 4:47 AM
NCT ID:
NCT01311518
Eligibility Criteria:
Inclusion Criteria:
1. Male and female subjects
2. Negative urine pregnancy test at Screening
3. An electrocardiogram
4. First acute anterior MI
5. Baseline angiography
6. Onset of chest pain symptoms to initial PCI angioplasty time is 2 to 6 hours
7. Written informed consent reviewed and signed by the subject or legally authorized representatives
Exclusion Criteria:
1. Intention to treat subject with thrombolytic therapy following assertion of Thrombolysis In Myocardial Infarction(TIMI) flow 0 or 1 during qualifying angiogram
2. History of Myocardial infarctionI or congestive heart failure
3. Non-atherosclerotic etiology of acute myocardial infarction
4. Cardiogenic shock (systolic blood pressure \<90 despite adequate left ventricle filling pressure or requiring catecholamines) or other hemodynamic instability at baseline
5. Further transcatheter or surgical revascularization, e.g., coronary artery bypass graft planned per baseline angiogram
6. Lactating women
7. Past or present evidence of malignancy
8. Women who have had menarche but have not completed menopause, have not been surgically sterilized (bilateral tubal ligation or hysterectomy), do not have a partner with documented sterility (including vasectomy), or are not using adequate contraception (combined hormonal or double-barrier method of contraception, or sexual abstinence are the only methods of contraception acceptable for this study)
9. Ongoing infectious disease including human immunodeficiency virus (HIV) and hepatitis
10. Clinically significant respiratory, renal, metabolic, liver, central nervous system or other comorbid disease, except current cardiovascular disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01311518
Study Brief:
Protocol Section:
NCT01311518