Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluate the mean LVEF increase by magnetic resonance imaging (MRI) at 6 months of follow up between the stem cell group and the control group.
研究概览
简要总结
The purpose of this study is to evaluate the ejection fraction (EF) increase at 6 months follow up and major adverse cardiovascular events (MACE) after intracoronary autologous stem cell transplantation in ST elevation myocardial infarction patients versus a control group.
详细描述
Experimental trials with bone marrow cell have suggested that adult stem cell can contribute to regeneration of infarcted myocardial muscle and increase the neovascularization of the ischemic tissue.
Post-myocardial infarction heart failure secondary to ventricular remodelation it's an increasing problem. A novel therapeutic approach for decrease this consequence is to induce the angiogeneses and regeneration of myocardial cells.
Many trials have shown benefits through the intracoronary injection of stem cell, however the clinical benefit is still controversial. The present trial is a randomized single blinded controlled trial designed to evaluate the improvement on EF and survival in post ST elevation myocardial infarction patients undergoing to intracoronary autologous stem cell transplantation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender patients between 20 and 75 years old with an acute myocardial infarction (less 24 hrs of symptoms) undergoing to primary angioplasty.
- •LVEF < o = 45% by MRI, radioisotopic ventriculography or echocardiogram.
- •Informed written consent.
排除标准
- •Cardiogenic Shock.
- •Post-myocardial infarction mechanical complication
- •Malignant ventricular arrythmias
- •History of malignant disease during the last five years.
- •Pregnancy
- •Renal chronic disease with a creatinine level > 2.6 mg/dl.
- •Any kind of stroke during the last year.
- •Any chronic disease that can affect the patient survival during the trial.
结局指标
主要结局
Evaluate the mean LVEF increase by magnetic resonance imaging (MRI) at 6 months of follow up between the stem cell group and the control group.
时间窗: 6 months
次要结局
- Evaluate the left ventricular end diastolic volume (LVEDV) and left ventricular end systolic volume (LVESV)with image magnetic resonance(IMR) at 6 months follow up between stem cell and control group.(6 months)
- Evaluate the oxygen consumption during treadmill stress test (MVO2) by expired gases analysis and the incidence of MACE at 6 months follow up between stem cell and control group.(6 months)