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 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT03397095
Eligibility Criteria:
Inclusion Criteria:
1. Males and non-pregnant, non-lactating females;
2. Chronic ischemic heart failure, previous anterior myocardial infarction \> 3months;
3. Viable myocardium is detected by D-SPECT;
4. LVEF \< 50% measured by echocardiography or NYHA II-IV;
5. No planed reasonable revascularization procedures;
6. At least 30 days standard medical therapy for heart failure before screening;
7. Worsening heart failure within 6 months or have a NT-proBNP ≥1000 pg/mL or BNP ≥200 pg/mL within 30 days of screening (including screening); or have a 6-minute walk test (6MWT) distance of ≤425 meters at screening;
8. Written informed consent.
Exclusion Criteria:
1. Ventricular thrombus;
2. Myocardial infarction, TIA or stroke \< 3 months;
3. CRT/CRT-D implantation, heart transplantation, cardiomyoplasty, left ventricular reduction surgery, heart failure-related device interventions, or cardiac shunt implantation;
4. Active infection or fever;
5. Chronic inflammatory disease;
6. HIV infection or active hepatitis;
7. Hemoglobin A1c (HbA1c) ≥ 9% at screening;
8. Body mass index (BMI) ≥ 40 kg/m2 at screening;
9. Chronic kidney disease (CKD) requiring dialysis (Stage 5) or estimated creatinine clearance \< 30 mL/min/1.73㎡ at screening;
10. Allergies to any equine, porcine, or bovine products;
11. Abnormal laboratory values at screening：Platelets \< 50,000 μL;Hemoglobin \< 9.0 g/dL; Aspartate aminotransferase/alanine aminotransferase (AST/ALT) \> 3 times the upper limit of normal (ULN);
12. Pregnancy;
13. Mental retardation;
14. Participation in other clinical study \< 1 month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03397095
Study Brief:
Protocol Section:
NCT03397095