NCT00437710Unknown1 期
Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans
Azienda Unita Sanitaria Locale di Piacenza2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2005年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
We will study in a prospective randomised fashion 50 patients who will be treated by intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition to standard therapy after MI or standard therapy.
After standard therapy for acute MI, 10 patients were transplanted with autologous mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute MI were treated by standard therapy alone. After
详细描述
Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent acute transmural anterior myocardial infarction, (in agreement with WHO)
- •single left anterior descending coronary artery disease
- •<72 hour from the origin of symptoms
- •successful primary angioplasty of the culprit lesion
排除标准
- •screening >72 hours after infarction,
- •cardiac shock, severe comorbidity, alcohol or drug dependency
- •severe comorbidity (DM,renal or liver insufficiency)
- •potential child bearing woman
- •inability to provide informed consent
结局指标
主要结局
Mortality
Mortality and Morbidity
Left ventricular function
次要结局
- Left ventricular remodeling
- Heart rate variability
- Baroreflex sensitivity
- Stress induced myocardial ischemia
- Cell dose response
研究者
研究点 (2)
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