NCT00501917UnknownPhase 2
Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial
Seoul National University Hospital1 site in 1 country116 target enrollmentStarted: March 1, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- change of left ventricular ejection fraction measured by cardiac MRI
Study Overview
Brief Summary
Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 15 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ST elevation acute myocardial infarction
- •< 80years
- •successful revascularization of culprit vessel
Exclusion Criteria
- •uncontrolled congestive heart failure
- •uncontrolled myocardial ischemia
- •uncontrolled ventricular arrhythmia
- •malignancy
- •serious hematologic disease
- •chronic renal failure
Outcomes
Primary Outcomes
change of left ventricular ejection fraction measured by cardiac MRI
Time Frame: 6, 12, and 24month
Secondary Outcomes
- wall motion score index exercise capacity BNP(6,12, 24month)
Investigators
Study Sites (1)
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