NCT00529932终止不适用
A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
Jozef Bartunek6 个研究点 分布在 4 个国家目标入组 19 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 6
- 主要终点
- PRIMARY SAFETY ENDPOINT Comparison of progression in coronary atherosclerosis burden proximal and distal to the stented segment of the infarct-related artery in treated and control groups.
研究概览
简要总结
An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial with central core lab analyses to determine the safety of intra-coronary infusion of enriched CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days after acute percutaneous coronary revascularization (primary PCI) for ST-segment elevation myocardial infarction (STEMI).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary PCI for acute STEMI between 2-24 hours after onset of chest pain.
- •ST-segment elevation >=2mm in >=3 adjacent leads.
- •Presence of severe hypokinesia and/or akinesia in >=2 adjacent segments on echocardiogram at 48-72 hrs after primary PCI.
- •Age between 20 and 75 years.
排除标准
- •Pregnant or lactating.
- •Prior history of myocardial infarction before index event.
- •Decompensated congestive heart failure.
- •Pre-existent LV dysfunction (EF <45% prior to admission)
- •Cardiomyopathy.
- •Previous cardiac surgery.
- •Congenital heart disorder.
- •Serum creatinine >200 Mmol/L.
- •Presence of permanent pacemaker or implantable defibrillator.
- •Contraindication to bone marrow aspiration.
- •History of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma and/or cervical carcinoma.
- •Sustained or inducible VT >48 hours post primary PCI.
- •Three vessel coronary artery disease necessitating intervention within 4 months.
- •Immune compromise including chronic human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
- •Presence of chronic systemic inflammatory disorders.
- •Previous autologous or allogeneic bone marrow or peripheral stem cell transplant or prior solid organ transplantation.
- •Low hemoglobin, white blood cell, absolute neutrophil and/or platelet count.
- •Any condition associated with a life expectancy of less than 6 months.
- •Participation in unrelated research involving investigational pharmacological agent(s) 30 days before planned dosing.
- •Current alcohol or drug abuse.
- •Inability to provide written informed consent.
结局指标
主要结局
PRIMARY SAFETY ENDPOINT Comparison of progression in coronary atherosclerosis burden proximal and distal to the stented segment of the infarct-related artery in treated and control groups.
时间窗: at 6 months post-infusion
PRIMARY EFFICACY ENDPOINT Comparison of changes in myocardial thickening in non-viable akinetic / hypokinetic LV wall segments as determined by cardiac magnetic resonance imaging (cMRI) in treated and control groups.
时间窗: at 6 and 24 months
次要结局
- SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure.(At all follow up's)
- SECONDARY EFFICACY ENDPOINTS (a) Changes in % global LV ejection fraction (EF) compared with baseline as determined by cMRI and echocardiography pre- and post-cell infusion subsequent to primary PCI.(at all follow up's)
- SECONDARY EFFICACY ENDPOINTS (b)Assessment of epicardial resistance and microvascular resistance, index of myocardial resistance and absolute coronary blood flow measurements in the infarct related artery.(at 6 months follow up)
- SECONDARY EFFICACY ENDPOINTS (c) The feasibility of the CliniMACS® Reagent System to yield 5x106 CD133+ cells from 100-150 ml of autologous bone marrow.(prior to the infusion)
研究者
Jozef Bartunek
Jozef Bartunek
Onze Lieve Vrouw Hospital
研究点 (6)
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