ISRCTN49998633已完成不适用
INtramyocardial application of STEM cells in combination with transmyocardial laser revascularisation in coronary artery bypass graft patients
Heinrich-Heine-University (Germany)0 个研究点目标入组 40 人开始时间: 2007年6月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 18 years (male or female gender)
- •2. Presence of at least two vessel coronary artery disease with at least one vessel that is not amenable to CABG, according to the angiogram, this vessel must serve an area of viable myocardium
- •3. Area of interest defined as part of free left ventricular wall with reduced contractility as shown either in ventriculographia during angiography and/or preoperative echo
- •4. Demonstration of reduced perfusion in the area of interest by cardiac Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)
- •5. Global ejection fraction greater than 15% and less than 35%
- •6. Signed informed consent
排除标准
- •1. Any condition that in the belief of the treating physician prevents successful stem cell collection or application (e.g. systemic infection, puncture for stem cell collection impossible)
- •2. Any condition that may adversely affect bone marrow (such as malignancy or prior irradiation to the pelvic bone)
- •3. Mitral valve insufficiency greater than II
- •4. History of ventricular arrhythmia, not controlled by medication and/or Automatic Implantable Cardioverter Defibrillator (AICD) required
- •5. Need of additional heart surgery (i.e. valve replacement)
- •6. Emergency or salvage operation defined as within 48 hours of diagnosis
- •7. Evidence of left ventricular thrombus
- •8. Previous heart surgery within the last six months (excluding implantation of pacemaker)
- •9. History of symptomatic carotid disease (e.g. any Transient Ischaemic Attack [TIA], Prolonged Ischaemic Neurological Deficit [PRIND], stroke) within the last three months prior to study intervention
- •10. Increased Creatine Kinase (CK) (greater than three times normal) in patients with unstable angina
- •11. End Stage Renal Disease (ESRD) defined as serum creatinine level greater than 3.5 mg/dL, or dialysis (renal replacement therapy)
- •12. Concurrent active chemotherapy for cancer
- •13. Life expectancy less than two years
- •14. Platelet count less than 100000/µl
- •15. Pregnancy
- •16. Participation in other clinical trials in the last 30 days
- •17. Active hepatitis-infection
- •18. Human Immunodeficiency Virus (HIV)-infection
- •19. Anaemia
- •20. Haemorrhagic diathesis in medical history
- •21. Sensitivity and incompatibility against used drugs or excipients
- •22. Disseminated intravascular coagulation in medical history
- •23. Clinically active infection at the time of operation
- •24. Patient not able to attend follow-up as specified in the protocol
- •25. No informed consent
研究者
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