NCT00497211Unknown2 期
Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction
适应症
试验速览
- 阶段
- 2 期
- 试验地点
- 2
研究概览
简要总结
Large acute myocardial infarctions are the most frequent cause of subsequent systolic heart failure. Some evidence exists on the improvement after intracoronary administration of bone marrow cells in patients with a recente acute myocardial infarction. Although subgroup analyses suggest that patients with the largest myocardial infarctions have the largest increase in ejection fraction after intracoronary bone marrow administration, there is no published trial including only large myocardial infarctions. Therefor we sought to confirm the subgroup analyses by conducting a trial in only large first acute myocardial infarction patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥20 and <80 years old
- •Acute myocardial infarction >2 and <96 hours from start to reperfusion
- •Cumulative ST-segment elevation >6 mm on 12 lead ECG
- •No functional myocardial impairment outside the myocardial infarction region
- •Succesful PCI of infarct related coronary artery
- •Left ventricular ejection fraction <50% on ventriculography, echo or MRI
- •Accepted anticonceptive use during the study for women of childbearing potential
- •Written and signed informed consent
排除标准
- •CPR > 10 minuts or persistent cardiogenic shock
- •complete left bundle branch block without concordant ST-segment elevation
- •Need foor cardiac surgery (valvular, coronary or other)
- •Trombocytopenia, coagulation disorders or hematological disease
- •History or active malignancy
- •Life expectancy (apart from acute myocardial infarction) <5 years
- •Dialysis or severe kidney insufficiency (creatinin clearance <30ml/')
- •Severe liver insufficiency
- •Severe respiratory disease
- •Systemic inflammatory pathology (acute or chronic, apart from inflammation associated with myocardial infarction)
- •Symptomatic cerebral or periferal vascular disease
- •Prior myocardial infarction or prior myocardial dysfunction
- •Prior CABG or heart valve surgery
- •Pregnancy, pregnancy wish or lactation <1 month
- •Psychiatrical illness
- •Physical or psychological inability to adhere to the protocol
- •Participation in other not yet completed study
研究者
研究点 (2)
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