NCT00882466已完成4 期
Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Creatinine kinase (CK), creatinine kinase-MB (CK-MB)
研究概览
简要总结
The purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction <12hr
- •Age >18yrs
- •First myocardial infarction
- •culprit lesion : proximal to mid left anterior descending artery
- •Baseline coronary flow : TIMI Grade 0~1
排除标准
- •Patients with previous myocardial infarction
- •History of thrombotic complication
- •History of cerebral infarction
- •Uncontrolled hypertension
- •Increased hemoglobin level >17g/dL
- •Patients with mechanical valve
- •Cardiogenic shock
研究组 & 干预措施
EPO
Experimental
干预措施: human recombinant erythropoietin (Drug)
结局指标
主要结局
Creatinine kinase (CK), creatinine kinase-MB (CK-MB)
时间窗: 4hr, 8hr, 12hr, 24hr, 48hr, 72hr
次要结局
- Infarct size assessed by cardiac MRI(day 4)
研究者
研究点 (1)
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