Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)
研究概览
简要总结
Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.
详细描述
After successful percutaneous coronary intervention (PCI) for acute myocardial infarction, 100 patients are randomly assigned to either a control group (n=50) who receives an optimal medical treatment, or a bone-marrow-cell group (n=50) who receives an optimal medical treatment and intracoronary transfer of autologous bone-marrow cells 7•10 days after PCI.
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
- •Men or women between 18-75 years.
- •Acute myocardial infarction
- •Absence of viability in the infarcted zone and LVEF <45%.
排除标准
- •History of prior myocardial infarction
- •Significant stenosis in another coronary territory than the acutely treated vessel
结局指标
主要结局
Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)
时间窗: after 3 months and 1 year of treatment
次要结局
- Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection
- Left ventricle ejection fraction (LVEF) evaluated by radionuclide ventriculography, (3 and 12 months) and by echography (1, 3, 6, and 12 months). Segmental EF and myocardial viability evaluated by MRI (3 months)(after 1,3,6 ,12 months of treatment)