NCT01144221终止不适用
Protocol on an Evaluative Study on Bone Marrow Derived Mononuclear Cells for Optimization of Biventricular Pacing in Patients With Chronic Ischemic Left Ventricular Dysfunction
Kai Jaquet, PhD, DSc2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2010年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- LVEF Value
研究概览
简要总结
This is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •chronic left ventricular dysfunction (ejection fraction <35 %) in chronic ischemic heart disease and asynchronic contraction with indication for a biventricular stimulation (CRT, chronic resynchronization therapy), who do not have an improvement of >15% of LVEF 3 months after CRT-device implantation
- •wall motion dysfunction of any territory
- •left bundle branch block
- •Patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ACE-inhibitors, AT1 blockers and/or lipid lowering agents for at least 30 days before CRT Implantation
排除标准
- •patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy
- •with relevant valvular disease;
- •Aneurysma of the anterior myocardial wall or myocardial wall thickness of < 5 mm,
- •with overt heart failure, other than ischemic cardiomyopathy,
- •with history of stroke and/or transient ischemic attack (TIA),
- •with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system;
- •with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment;
- •with severe systemic disease - (e.g. known or suspected anaphylaxia, intolerance against X-ray or contrast agent and, pre-malignant and malignant disease)
- •atrial fibrillation with average heart rate >70 bpm
- •pregnant women and women of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment;
- •with any disease or condition that seriously compromises the function of other body systems than the heart and/or might interfere with conduct of the study and interpretation of the results;
- •patients with a chronic or acute HIV-, HBV-, HCV-infection;
- •improvement of more than 15% of LVEF 3 months after CRT-device implantation
- •patients who have a ICD Implantation for secondary prophylactic indication. These patients show a history of resuscitation, VT or syncope.
- •patients who are currently participating in another investigational drug or device study
研究组 & 干预措施
Stem cell treatment
Experimental
Patients treated via stem cell injection
干预措施: Intramyocardial Cell therapy (Procedure)
结局指标
主要结局
LVEF Value
时间窗: 12 months
LVEF values will be compared after ICD CRT-Implantation and after Bone Marrow Derived Mononuclear Cells Injection
次要结局
未报告次要终点
研究者
Kai Jaquet, PhD, DSc
Head of Stem Cell Lab
Asklepios proresearch
研究点 (2)
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