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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT00430820
Eligibility Criteria:
Inclusion Criteria:
* Group 1 (Non-ST-elevation acute myocardial infarction) :
* Chest pain less than 48 hours before admission,
* And modifications of ST-T (no persistent ST elevation) on 12-lead EKG,
* And elevation of troponin-I \>1xN,
* And presence of ≥1 de novo stenosis(es) \>50% located on ≥1 native coronary artery(ies) and successfully treated using percutaneous coronary intervention and stenting.
* Group 2 (Stable coronary artery disease) :
* Documented myocardial ischemia (stable angina or positive stress test)
* And presence of ≥1 de novo stenosis(es) \>50% located on ≥1 native coronary artery(ies) and successfully treated using percutaneous coronary intervention and stenting.
* Group 3 (Normal coronary arteries) :
* No history of coronary artery disease, neurovascular disease or peripheral artery disease,
* And normal coronary angiography performed because of suspected coronary artery disease
* And absence of significant functional or anatomic abnormalities suggestive of atherosclerosis on non-invasive arterial studies (measurements of intima-media thickness, pulse wave velocity, ankle-brachial index, …).
Exclusion Criteria:
* Group 1 :
* Preexisting EKG abnormalities (including left bundle branch block) precluding accurate assessment of ST-T changes
* Group 2 :
* History of acute coronary syndrome
* Groups 1 and 2:
* Culprit coronary artery stenosis is a restenosis or a stent thrombosis or is located in a bypass graft.
* All groups :
* Heart failure (NYHA class ≥II)
* Left ventricular ejection fraction \<50%
* Severe valvular heart disease requiring surgical or percutaneous therapy
* History of autoimmune, inflammatory or neoplasia diseases ; or infectious disease in the month before admission
* Life expectancy \< 1 year
* Age \<18 years or \>80 years
* Current pregnancy or breast-feeding
* Homeless or travelers who may not be followed-up
* Refusal to sign the informed consent form
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00430820
Study Brief:
Protocol Section:
NCT00430820