NCT00691834撤回2 期
ReNEW: A Phase 2, Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Autologous Bone Marrow Mononuclear Cell Transfer for Myocardial Salvage in Acute Myocardial Infarction
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients
研究概览
简要总结
The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Be at least 18 years of age and no more than 80 years of age.
- •Acute ST-segment elevation MI
- •Symptoms suggestive of acute MI
- •≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block
- •Time from symptom onset to enrollment < 120 hours
- •Left ventricular dysfunction by contrast ventriculography or echocardiography
- •EF above 25 % and lower than 40%
- •Focal wall motion akinesis or dyskinesis
- •Clearly identifiable infarct artery
- •Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement
排除标准
- •Planned treatment with bypass surgery or prior CABG
- •Multi-vessel PCI
- •Prior myocardial infarction by history or presence of pathologic Q-waves
- •Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes
- •Successful reperfusion < 3 hrs from symptom onset
- •Prior MI or significant chronic heart failure
- •Pacemaker/defibrillator
- •Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat)
- •Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance<25 and/or serum Cr >2.5 mg/dl)
- •Baseline hematocrit < 30
- •Pregnancy, or lactation/parturition within the past 30 days
- •Active or planned treatment with chemotherapy
- •Anticipated difficulty with 90-day follow-up
- •Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive
- •Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial
- •Previous enrollment in this trial
- •Participation in an investigational drug or device study within the past 30 days
结局指标
主要结局
Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients
时间窗: baseline and 90 days
Occurence of arrhythmia, heart failure and death
时间窗: 1 year
次要结局
- Improvement in regional left ventricular function(90 days)
研究者
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