NCT00501917Unknown2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- change of left ventricular ejection fraction measured by cardiac MRI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST elevation acute myocardial infarction
- •< 80years
- •successful revascularization of culprit vessel
排除标准
- •uncontrolled congestive heart failure
- •uncontrolled myocardial ischemia
- •uncontrolled ventricular arrhythmia
- •malignancy
- •serious hematologic disease
- •chronic renal failure
结局指标
主要结局
change of left ventricular ejection fraction measured by cardiac MRI
时间窗: 6, 12, and 24month
次要结局
- wall motion score index exercise capacity BNP(6,12, 24month)
研究者
研究点 (2)
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