Myocardial REGeneration by Intracoronary Infusion of Selected Population of stEm Cells in Acute Myocardial iNfarcTion. Randomized Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Left ventricular ejection fraction and volumes measured by echocardiography
研究概览
简要总结
The purpose of the study is to compare the efficiency of a sorted subpopulation of CD34+/CXCR4+ cells and unselected bone marrow-derived progenitor cells in the treatment of patients with acute myocardial infarction and a low left ventricular ejection fraction.
详细描述
Aim is to compare the efficiency of sorted subpopulation of CD34+/CXCR4+ cells and unselected bone-marrow-derived progenitor cells in treatment of patients with acute myocardial infarction and low left ventricular ejection fraction. The subpopulation of CD34+/CXCR4+ cells most likely contains the tissue-specific stem cells likely to be involved in myocardial salvage/regeneration after ischemic injury. This approach is novel and original, because so far no study identified the type of cells that actually contribute to stem cell-induced improvement in myocardial function in patients with AMI which were treated with unselected population of cells. The REGENT trial (prospective, randomized, multicentre trial comparing unselected BM mononuclear cells and sorted CD34/CXCR4+ cells in patients with myocardial infarction and low left ventricular ejection fraction) successfully treated with primary percutaneous coronary angioplasty within 12 hours after the onset of chest pain. The cells are delivered by intracoronary infusion. Efficiency is assessed by cardiac magnetic resonance imaging, echocardiography and left ventricular angiography.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction treated successfully with primary coronary angioplasty
- •Left ventricular ejection fraction less than 40%
- •Informed consent granted
排除标准
- •Presence of significant coronary stenoses in non-infarct related artery requiring revascularization
- •Cardiogenic shock
- •Previous myocardial infarction
- •Age < 18 years and > 75 years
- •Pregnancy
- •Contraindications for MRI
结局指标
主要结局
Left ventricular ejection fraction and volumes measured by echocardiography
时间窗: 6 months
Left ventricular ejection fraction and volumes measured by angiography
时间窗: 6 months
次要结局
- Safety(6, 12 months)
- Left ventricular function in dobutamine stress test(6 months)
- Coronary flow reserve by adenosine MRI test(6 months)