NCT00765453已完成不适用
Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Longitudinal change in left ventricular function (ejection fraction)
研究概览
简要总结
Study hypothesis :
The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.
Aims
- To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure
- To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.
- To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.
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
- Triple (Participant, Care Provider, 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
- •Patients presenting to the Heart Attack Centre with acute anterior myocardial infarction (ST elevation in at least 2 contiguous anterior leads ≥ 0.2 mV) and treated with acute PCI with stent implantation within 24 hours after symptom onset
- •Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2).
- •At the time of inclusion patient no longer requires i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- •Significant regional wall motion abnormality in LV angiogram at the time of acute PCI in the LAD territory
- •Age 18 - 80 Years (primary angioplasty confers an adverse prognosis in those over the age of 80 years)
- •Written informed consent in the recruiting centres native language
排除标准
- •Regional wall motion abnormality outside the area involved in the index acute myocardial infarction
- •Need to revascularise additional vessels, outside the infarct artery as a planned procedure (these vessels can be treated at baseline)
- •Arteriovenous malformations or aneurysms
- •Active infection, or fever or diarrhoea within last 4 weeks
- •Chronic inflammatory disease
- •Known HIV infection or active hepatitis
- •Neoplastic disease without documented remission within the past 5 years
- •Cerebrovascular insult within 3 months
- •Impaired renal function (creatinine > 200mmol) at the time of cell therapy
- •Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
- •Anemia (hemoglobin < 8.5 mg/dl)
- •Platelet count < 100.000/µl
- •Hypersplenism
- •Known allergy or intolerance to clopidogrel, heparin or abciximab
- •History of bleeding disorder
- •Gastrointestinal bleeding within 3 months
- •Major surgical procedure or trauma within 2 months
- •Uncontrolled hypertension
- •Pregnancy
- •Mental retardation leading to inability to obtain informed consent
- •Previously performed stem / progenitor cell therapy
- •Participation in another clinical trial within the last 30 days
结局指标
主要结局
Longitudinal change in left ventricular function (ejection fraction)
时间窗: 1 year
次要结局
- Longitudinal change in left ventricular function as measured by LV angiography(6 months)
- Longitudinal change in left ventricular function assessed by echocardiography.(12 months)
- Change in Quality of life(6 and 12 months)
- Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size(3 months)
- Change in left ventricular end systolic volume and change in infarct size.(12 months)
- MACE(12 months)
研究者
Anthony Mathur
Professor
Barts & The London NHS Trust
研究点 (6)
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