Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells
Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells
研究概览
详细说明
Primary coronary intervention within a few hours of a myocardial infarction has greatly reduced mortality as well as the risk of developing chronic heart failure. There are though still a large number of patients that develop symptoms of heart failure in the form of fatigue and breathlessness with physical exertion in spite of medical treatment. With the advance in stem cell technology there is now hope for the possibility of regenerating/repairing dead myocardial tissue, hence improving cardiac function.
The current study is a pilot study that is going to precede a later double blinded randomized study. The aim of the study is to evaluate patient safety, optimize procedures, and to be used in power calculation in the design of the following study.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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Odense、丹麦、5000
- 招聘中
- Department of endocrinology M, Odense University Hospital
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副研究员:
- Malthe AM Kristiansen, MD
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首席研究员:
- Moustapha Kassem, MD, Ph.D
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Chestpain
- Troponin T, > 0,1ng/ml
- Succesfull revascularization of culprit lesion with PCI.
- No more than stenosis of 2 major epicardiel coronary arteries.
Exclusion Criteria:
- Cardiogenic shock
- Known LVEF<45%
- Cardiomyopathy
- Atrialfibrillation or fluctuation
- Takyarytmia
- Infection
- Chronic inflammatory disease
学习计划
研究是如何设计的?
设计细节
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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安全
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次要结果测量
结果测量 |
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Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography
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合作者和调查者
调查人员
- 首席研究员:Moustapha Kassem, MD, Ph.D、Department of endocrinology M, Odense University Hospital
出版物和有用的链接
一般刊物
- Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H. Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial. Lancet. 2004 Jul 10-16;364(9429):141-8. doi: 10.1016/S0140-6736(04)16626-9.
- Schachinger V, Assmus B, Britten MB, Honold J, Lehmann R, Teupe C, Abolmaali ND, Vogl TJ, Hofmann WK, Martin H, Dimmeler S, Zeiher AM. Transplantation of progenitor cells and regeneration enhancement in acute myocardial infarction: final one-year results of the TOPCARE-AMI Trial. J Am Coll Cardiol. 2004 Oct 19;44(8):1690-9. doi: 10.1016/j.jacc.2004.08.014.
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 020
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