NCT00938847已完成3 期
Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration in Early Left Ventricular Dysfunction After Acute Myocardial Infarction And Successful Percutaneous Coronary Intervention
Asklepios proresearch2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年2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
- 20
- 试验地点
- 2
- 主要终点
- Demonstration of safety and feasibility of BM-MNC treatment. Investigation of the suitability of endocardial left ventricular electromechanical mapping (LVEMM) with NOGA as endpoint for myocardial regeneration.
研究概览
简要总结
Evaluative pilot study for safety and feasibility with administration of autologous bone bone marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo the ischemic lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •LVEF <40%
- •PCI at latest 6 hours after infarction
- •BMI >20 kg/m² and <30 kg/m²
排除标准
- •PCI elder than 14 days
- •relevant valvular disease
- •left ventricular dysfunction caused by other reasons than ischemic cardiomyopathy
- •history of stroke, chronic atrial fibrillation, multivessel disease, thromboembolic event
- •scheduled for CABG
- •DM Type 1 & extensive hypercholesterinemia
- •pacemaker
- •systemic disease
- •Pregnancy
结局指标
主要结局
Demonstration of safety and feasibility of BM-MNC treatment. Investigation of the suitability of endocardial left ventricular electromechanical mapping (LVEMM) with NOGA as endpoint for myocardial regeneration.
时间窗: 12 months
次要结局
- Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.(12 months)
研究者
研究点 (2)
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