Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Left Ventricular Ejection Fraction(LVEF)
研究概览
简要总结
The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Our aim was to investigate 4 years' efficacy and LV functional improvement of autologous bone marrow mononuclear cells (BMMC) transplantation in patients with ST-elevation myocardial infarction.
详细描述
The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results.
Aim is to evaluate the long term efficiency of unselected bone marrow mononuclear cells in treatment of patients with ST-elevation myocardial infarction (STEMI), especially with regard to the left ventricular function. The cells are delivered by intracoronary infusion 7 days after the PCI. Outcomes including LVEF, myocardial viability and coronary artery status are assessed by echocardiography, SPECT and coronary angiography.
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
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST segment elevation myocardial infarction, according to the WHO definition.
- •<24 hour from the origin of symptoms.
- •Single left anterior descending coronary artery disease.
- •Successful revascularization of culprit lesion with PCI.
- •Age between 45 and 65 years old.
- •Written informed consent.
排除标准
- •Previous MI.
- •Cardiomyopathy.
- •Atrial fibrillation or fluctuation.
- •Previous heart surgery.
- •Severe valvular heart disease.
- •Disease of the hematopoetic system.
- •NYHA functional class IV at baseline.
- •Severe renal, lung and liver disease or cancer.
- •Significant coronary lesion in one or more major coronary vessels, requiring revascularization.
- •Intra-cardiac thrombus.
结局指标
主要结局
Left Ventricular Ejection Fraction(LVEF)
时间窗: 1, 3, 6 months, 1, 4 years
次要结局
- in-stent restenosis(1, 3, 6 months, 1, 4 years)
- cardiac shock(1, 3, 6 months, 1, 4 years)
- myocardial viability of the infarcted area(1, 3, 6 months, 1, 4 years)
- end-diastolic Volume/end-systolic Volume(EDV/ESV)(1, 3, 6 months, 1, 4 years)
- wall motion score index(WMSI)(1, 3, 6 months, 1, 4 years)
- cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization)(1, 3, 6 months, 1, 4 years)