NCT00279175已完成3 期
Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Myocardial Infarction (REPAIR - AMI)
A. M. Zeiher34 个研究点 分布在 2 个国家目标入组 204 人开始时间: 2004年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 34
- 主要终点
- Change in global left ventricular function in quantitative LV angiography after 4 months.
研究概览
简要总结
Impaired contractile function after a heart attack of the heart is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy, including immediate balloon/stent dilation of the infarct vessel.
The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into the infarct vessel (after successful reperfusion therapy) may improve left ventricular contractile function compared to placebo therapy. After bone marrow aspiration progenitor cells are enriched via a centrifugation method.
详细描述
- The study is a double-blind, placebo-controlled, randomized, multicenter trial.
- Patients after an acute myocardial infarction, undergoing successful reperfusion therapy are included.
- All patients undergo bone marrow aspiration 3 to 6 days after the infarction.
- After cell processing, enriched bone marrow-derived progenitor cells or placebo medium is infused direct into the infarct related artery during stop-flow. In addition, a left ventricular angiography is performed.
- After 4 months left ventricular angiography is repeated. The primary endpoint is the difference in change of left ventricular ejection fraction between the two groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute myocardial infarction (ST elevation in at least 2 leads >= 0.2 mV in V1,V2 or V3 or >= 0.1 mV in other leads), treated by one of the following procedures
- •Either acute PCI with stent implantation within 24 hours after symptom onset or
- •treatment with thrombolysis within 12 hours of symptom onset followed by PCI with stent implantation within 24 hours after thrombolysis.
- •Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow >= 2).
- •At the time of inclusion patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- •Significant regional wall motion abnormality in LV angiogram at the time of acute PCI (ejection fraction <= 45% on visual estimation).
- •Maximal CK elevation >= 400 U/l (measured at 37° C) with significant MB fraction > 6%
- •Age 18 - 80 Years
- •Written informed consent
排除标准
- •Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
- •Need to revascularize additional vessels, outside the infarct artery.
- •Arteriovenous malformations or aneurysms
- •Active infection (CRP > 10 mg/dl) now, or fever or diarrhea within last 4 weeks.
- •Chronic inflammatory disease
- •HIV infection or active hepatitis
- •Neoplastic disease without documented remission within the past 5 years.
- •Cerebrovascular insult within 3 months
- •Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy
- •Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
- •Anemia (hemoglobin < 8.5 mg/dl)
- •Platelet count < 100.000/µl
- •Hypersplenism
- •Known allergy or intolerance to clopidogrel, heparin or abciximab.
- •History of bleeding disorder
- •Gastrointestinal bleeding within 3 months
- •Major surgical procedure or traumata within 2 months
- •Uncontrolled hypertension
- •Pregnancy
- •Mental retardation
- •Previously performed stem / progenitor cell therapy
- •Participation in another clinical trial within the last 30 days.
结局指标
主要结局
Change in global left ventricular function in quantitative LV angiography after 4 months.
时间窗: baseline to 4 months
absolute delta LVEF (%)
次要结局
- Primary endpoint in patients without restenosis.(baseline to 4 months)
- Improvement of regional wall motion in infarct area(baseline to 4 months)
- Reduction of LV end-systolic volume(baseline to 4 months)
- Major adverse cardiac events (MACE)(at 4, 12 and 60 months)
- Rehospitalization due to heart failure.(4, 12, 60 months)
- NYHA status after 12 months(12 months)
- Amendment for extended follow up after 2 and 5 years:(24 and 60 months)
- outcomes in major adverse cardiac events (MACE)(4, 12, 60 months)
- Rehospitalization due to heart failure(4, 12, 60 months)
- NYHA status(4, 12, 60 months)
- patients in MRI subgroup: improvement in left ventricular function(4, 12, 60 months)
研究者
A. M. Zeiher
Professor Dr. med.
Johann Wolfgang Goethe University Hospital
研究点 (34)
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