NCT00102128终止2 期
Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure
Genzyme, a Sanofi Company28 个研究点 分布在 6 个国家开始时间: 2002年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 试验地点
- 28
- 主要终点
- Recovery of contractility within previously akinetic areas of the heart (areas without motion/contraction) that have received treatment (cells from the patient's thigh muscle or placebo), and change in left ventricular EF as assessed by echocardiography
研究概览
简要总结
Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.
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
- Double
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
- •Patients recommended for coronary bypass surgery (preferably with cardiopulmonary support)
- •Ejection fraction ≥15% and ≤35%
- •Left ventricular myocardial infarction (MI - heart attack) ≥4 weeks prior to screening
排除标准
- •Need for a rapid surgical coronary revascularization
- •Need for any other related cardiosurgical measure during coronary surgery (e.g. mitral valve repair or valve replacement)
- •Patients with a left ventricular aneurysm who is a candidate for left ventricular aneurysmectomy or left ventricular reduction surgery; patient receiving left or biventricular (BiV) pacing therapy for heart failure (unless the patient has stabilized after 6 or more months of this therapy)
- •Cardiomyopathy presumed to be of non-ischemic origin
结局指标
主要结局
Recovery of contractility within previously akinetic areas of the heart (areas without motion/contraction) that have received treatment (cells from the patient's thigh muscle or placebo), and change in left ventricular EF as assessed by echocardiography
次要结局
- Time-to-first major adverse cardiac event (cardiovascular related death, non-cardiovascular death, congestive heart failure, resuscitated sudden death, myocardial infarction (heart attack) and stroke.
研究者
研究点 (28)
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