Autologous Stem Cell Transplantation in Acute Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
研究概览
简要总结
Objectives
Intracoronary transplantation of different cell populations have been used in acute myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI.
Design
The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days after PCI or to control. Left ventricular function, exercise capacity, biochemical status, functional class, quality of life and complications are validated at baseline and during a 12-month follow up.
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
- Single
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 40-75 years
- •anterior wall AMI with 120-720 minutes from onset of symptoms to PCI
- •ST elevation on ECG according to WHO criteria
- •angiographically significant stenosis on LAD proximal to the second diagonal branch
- •successful PCI with stenting of culprit lesion
- •hypokinetic, akinetic or dyskinetic segments assessed by echocardiography in a standard 16 segment model and
- •CK-MB above 3 times upper reference value.
排除标准
- •previous MI with established significant Q-waves on ECG
- •cardiogenic shock
- •permanent pacemaker or other contraindication to MRI
- •stroke with significant sequela
- •short life expectancy due to extra cardiac reason
- •uncontrolled endocrinological disturbance
- •HIV and/or HBV/HCV positive serology
- •mental disorder or other condition which interferes with patient possibility to comply with the protocol.
结局指标
主要结局
whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
次要结局
- To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry
- To test whether mBMC treatment improve quality of life assessed by the SF 36 formula