Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up
研究概览
简要总结
Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.
详细描述
There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute myocardial infarction with time to revascularization >6 hours from symptom start
- •clear target vessel
- •large myocardial infarction defined as: proximal vessel occlusion, CK > 1000 U/L, myocardial scar in magnetic resonance imaging > 10% of left ventricular muscle mass
- •potential prior thrombolysis
- •written informed consent
排除标准
- •acute myocardial infarction with revascularization within 6 hours after symptom start
- •prior myocardial infarction
- •no clear target vessel
- •contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
- •severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
- •prior hematologic disease
- •prior chemo therapy
- •prior stem cell transplantation
- •prior treatment with G-CSF
- •known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis
- •local infection of puncture sites
结局指标
主要结局
difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up
时间窗: 6 months
次要结局
- left ventricular ejection fraction measured by magnetic resonance imaging(1, 3, 12 months)
- left ventricular enddiastolic volume measured by magnetic resonance imaging(1, 3, 6, 12 months)
- left ventricular endsystolic volume measured by magnetic resonance imaging(1, 3, 6, 12 months)
- major adverse cardiac events(1, 3, 6, 12 months)
研究者
Jochen Wohrle
Prof. Dr. Jochen Wöhrle
University of Ulm