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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT01764334
Eligibility Criteria:
Inclusion Criteria:
1. NSTEMI with an elevated troponin (\> upper limit of normal for local reference range) with at least one CAD risk factor (e.g. diabetes, age \> 65 years, prior CAD, prior peripheral vascular disease, hypertension, hyperlipidaemia, family history of CAD).
2. At least one coronary lesion ≥ 30% stenosis severity.
3. Invasive management scheduled within 10 days of admission and ideally performed within 72 h of admission or a history of recurrent ischemic symptoms within 5 days.
Exclusion Criteria:
1. On-going ischemic symptoms (i.e. chest pain) not controlled by medical therapy.
2. Cardiogenic shock or hemodynamic instability.
3. Angiographic exclusion: highly tortuous or calcified arteries, left main stenosis \>80% angiographically (i.e. consistent with severe left main disease).
4. Life expectancy of \< 1 year.
5. MI with persistent ST elevation.
6. Intolerance to anti-platelet drugs.
7. Unsuitable for either PCI or CABG on clinical or angiographic grounds.
8. Coronary artery disease \< 30% reference vessel diameter.
9. Absence of a non-flow limiting coronary stenosis ≥30%.
10. Non-coronary cardiac surgery (e.g. concomitant valve repair or replacement).
11. Inability to give informed consent.
12. Age \< 18 years (no upper age limit).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01764334
Study Brief:
Protocol Section:
NCT01764334