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
- 终止
- 发起方
- 入组人数
- 300
- 试验地点
- 12
- 主要终点
- Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.
研究概览
简要总结
This study was designed to test the hypothesis that direct injection of bone-marrow cells in the heart may increase the number of blood vessels, ameliorating the heart's performance, and relieving patients from symptoms like angina and/or shortness of breath.
详细描述
Severe ischemic heart disease (IHD) remains a clinical challenge; many patients with IHD have undergone myocardial revascularization procedures (either percutaneous or surgical) but still remain symptomatic despite maximally tolerated medical therapy. Others are considered non-optimal candidates for a complete myocardial revascularization procedure due to the extension and diffuseness of the disease.
Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy being tested for many cardiovascular diseases, including heart failure, acute myocardial infarction, chronic ischemic heart disease.
The primary objective of this study is to assess the efficacy of intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG).
The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class (angina/heart failure), functional capacity, global and cardiovascular mortality, and quality of life in patients undergoing coronary artery bypass surgery (CABG).
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
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic, severe, diffuse, multivessel atherosclerotic coronary artery disease (CAD) referred for CABG.
- •Echocardiogram-assessed LVEF between 25 and 55% (Simpson's rule).
- •Angina (or equivalent) functional class II to IV (Canadian Cardiovascular Society) despite maximally tolerated medical therapy.
- •Abnormal myocardial perfusion tests:
- •i. Cardiac scintigraphy ii. Magnetic resonance imaging iii. Dobutamine-atropine stress-echocardiogram
- •Non-candidates for a percutaneous coronary intervention (PCI) due to ANY of the following:
- •i. High risk lesion ii. Extensive lesion iii. Diffuse, small vessel disease
- •Non-candidates for a complete CABG, or candidates for a complete CABG in whom, according to an expert panel, there is a high probability of failure of the grafts due to the extension and severity of the disease, with diffuse, small vessel involvement.
- •To provide a signed, written informed consent, according to the National Guidelines for Clinical Trials.
排除标准
- •Severe valve heart disease requiring surgical repair.
- •Serologic diagnostic of Chagas' disease.
- •Symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia.
- •Malignant ventricular arrhythmias (like VT), unless an ICD have been placed.
- •Any acute coronary syndrome in the past 3 months.
- •End-stage renal disease requiring maintenance dialysis.
- •History of neoplasia.
- •Drug or alcohol abuse.
- •Life expectancy below 2 years.
- •Enrollment in any cell therapy trial in the past 2 years.
结局指标
主要结局
Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.
次要结局
- All-cause and cardiovascular mortality during the first year; increase in VO2max, increase in quality of life, reduction in angina/heart failure functional class at 12 months; percentage of patients with a 5% increase in LVEF at 6 and 12 months.