NCT00841958已完成3 期
Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 2 个国家目标入组 250 人开始时间: 2007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
- 250
- 试验地点
- 2
- 主要终点
- Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: Ө ≤ 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: Ө > 1
研究概览
简要总结
The primary objective of this study is to test that endocardial stem cells implantation in patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and PCI or despite on previous revascularization improves long-term survival compared to MED alone
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 (Participant)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women who are not of childbearing potential
- •Age 21-75 years.
- •Patients with CAD, NYHA and CCS angina III-IV functional class
- •LVEF less than 35% measured by echocardiography or SPECT within three months of study entry
- •Unsuitable for initial or repeated conventional revascularization (CABG or PCI)
排除标准
- •Failure to provide informed consent.
- •Plan for PCI or CABG.
- •Non-cardiac illness with a life expectancy of less than 3 year.
- •Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
- •Previous heart, kidney, liver, or lung transplantation.
- •Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
- •Recent acute myocardial infarction (AMI) within 90 days of study entry
- •Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment
- •History of moderate to severe aortic stenosis or prosthetic aortic valve
- •Permanent atrial fibrillation
- •Thrombosis in LV, based on echocardiography data
结局指标
主要结局
Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: Ө ≤ 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: Ө > 1
时间窗: 2007-2010
次要结局
未报告次要终点
研究者
研究点 (2)
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