A Randomized Clinical Trial of Stem Cell Mobilization by Granulocyte-Colony-Stimulating Factor in Patients With Acute Myocardial Infarction. Regenerate Vital Myocardium by Vigorous Activation of Bone Marrow Stem Cells (REVIVAL-2) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Reduction of infarct size (measured by Tc-sestamibi scintigraphy)
研究概览
简要总结
The purpose of this study is to determine whether stem cell mobilization by granulocyte colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after successful mechanical reperfusion reduces infarct size.
详细描述
Experimental studies and early-phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived progenitor cells may improve cardiac regeneration after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells and, thereby, increases the number of circulating stem cells that are available cells for myocardial regeneration.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST-elevation acute myocardial infarction (5 days before randomization)
- •Successful percutaneous coronary intervention [PCI] (performed within 12 hours from symptom onset)
- •Scintigraphic infarct size >5% of left ventricle
- •Written informed consent
排除标准
- •Age <18 years or >80 years
- •Congestive heart failure defined as Killip class >2
- •A history of myocardial infarction
- •Electrical or hemodynamic instability
- •Autoimmune diseases
- •Fructose intolerance
- •Malignancies
- •Incompatibility of filgrastim
- •Known or suspected pregnancy
研究组 & 干预措施
1
Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.
干预措施: G-CSF Granulocyte-Colony Stimulating Factor (Drug)
2
Patients were randomly assigned to receive subcutaneously a daily dose of placebo for 5 days.
干预措施: Placebo (Other)
结局指标
主要结局
Reduction of infarct size (measured by Tc-sestamibi scintigraphy)
时间窗: measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months
次要结局
- Left ventricular ejection fraction(Left ventricular ejection fraction)
- Incidence of angiographic restenosis(6 months)