A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Increase in myocardial perfusion
研究概览
简要总结
Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization.
This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.
详细描述
All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery.
During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.
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
- Double (Participant, Investigator)
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
- •symptoms of angina or angina equivalent
- •documented coronary artery disease (invasive angiography)
- •documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI)
- •unsuitable for complete myocardial revascularization (PCI or CABG) OR even if a complete procedure in feasible, it is anticipated that myocardial perfusion may not be restored due to poor distal beds
排除标准
- •severe LV dysfunction (EF < 25% on echo)
- •short life expectacy (below < 1 year)
- •diagnosis of cancer in the past 5 years
- •diagnosis of hematological diseases
- •diagnosis of severe heart disease of other etiologies including valvular heart disease, Chagas' disease, etc)
- •diagnosis of acute coronary syndrome in the past 3 months
- •diagnosis of chronic kidney disease stage V requiring chronic dialysis
研究组 & 干预措施
Cell Therapy
Intramyocardial injection of autologous bone marrow-derived cells
干预措施: Cell Therapy (Procedure)
Placebo
Saline injection
结局指标
主要结局
Increase in myocardial perfusion
时间窗: 1, 6 and 12 months
Patients will undergo myocardial perfusion assessment by MRI during pharmacological stress with adenosine or dipyridamole. Alternatively, cardiac scintigraphy can be used in patients with contra-indications to MRI.
次要结局
- Improvement in LV function(1, 6 and 12 months)
研究者
Luis Henrique W Gowdak, MD, PhD
Clinical Coordinator
Ministry of Health, Brazil