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 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT00981006
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of ischemic cardiomyopathy
* Ischemic cardiomyopathy with old myocardial infarction due to coronary artery atherosclerotic disease.
2. Age: 20 to 80 years old
3. left ventricle (LV) dysfunction : An ejection fraction (EF)≧15%, and ≦35% assessed by echocardiography
4. Refractory heart failure: American Heart Association (AHA)/American College of Cardiology (ACC)heart failure Stage D
5. Heart failure symptom: New York Heart Association (NYHA) Class III or IV
6. An indication for CABG:A myocardial ischemia according to major coronary artery stenosis (\>75%)
7. Viability in the infarct area as measured by cardiac delayed hyperenhancement magnetic resonance imaging (MRI)
* Infarct area affecting \>2 contiguous LV segments in a 18-segment model
* The number of segments which transmural extent of hyperenhancement more than 51% is less than one.
* Ex1. infarct area with or without bypass graft.
* Ex2. no correlation with graft number.
* Ex3. in case of multiple myocardial infarction, an indication for larger in infarct volume.
8. written informed consent
Exclusion Criteria:
1. New onset of myocardial infarction or unstable angina within 28 days prior to study entry
2. Indication for surgical ventricular reconstruction or mitral valve repair \*1
3. Contraindication for endomyocardial biopsy \*2
4. Evidence for malignant disease within 3 years prior to study entry
5. Chronic hemodialysis
6. Liver Cirrhosis (ICGR 15 \>30%)
7. Uncontrollable diabetes mellitus (HbA1c\>8.0)
8. Maximum diameter of Aortic aneurysm more than 5.5 cm.(including dissecting aneurysm)
9. Cardiogenic shock
10. Active infection (including cytomegalovirus infection)
11. Drug or alcoholic dependency
12. Positive for HIV antigen
13. Active bleeding state (gastric ulcer, cerebral bleeding, etc.)
14. Gelatin allergy \*3
15. Chromosomal abnormality
* 1 an indication for LV aneurysmectomy; patients with over 2 segments of dyskinesis area
* 2 contra-indication for endomyocardial biopsy
* cardiogenic shock
* end-stage or uncontrollable congestive heart failure without continues infusion of catecholamine
* complete or mobitz type atria-ventricular block
* 3 The screening of gelatin allergy is necessary for all patients by gelatin patch test and gelatin-immunoglobulin E.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT00981006
Study Brief:
Protocol Section:
NCT00981006