NCT01216995已完成2 期
A Phase II Trial of Safety and Efficacy of ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction - The ADVANCE Study
Cytori Therapeutics7 个研究点 分布在 2 个国家目标入组 23 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 7
- 主要终点
- Reduction in Infarct Size
研究概览
简要总结
Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).
详细描述
This is a prospective, randomized, two arm, placebo-controlled, double blind, study that will enroll approximately 216 patients at no more than thirty-five (35) international clinical sites. Additional blinding measures will be taken in the assessment of study outcomes. The dose of the test material (ADRCs)is described in the protocol. The study will include two arms.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST-segment Elevation Myocardial Infarction (STEMI) Criteria:
- •Ischemic symptoms AND
- •Development of pathologic Q waves on the ECG; or
- •ECG changes indicative of severe ischemia (ST segment elevation and/or depression); or
- •New left bundle branch block; AND
- •Creatine Phosphokinase Isoenzyme (MB Form) > 100 IU/L, or troponin >5x the upper limit of normal between admission and randomization
- •Successful revascularization of the culprit lesion in a major epicardial vessel
排除标准
- •More than 24 hours between PCI and start of liposuction
- •Prior myocardial infarction, cardiomyopathy, or a history of congestive heart failure
- •Pacemaker, ICD, or any other contra-indication for MRI
- •Patients with increased bleeding risk
- •Cardiogenic shock present post-index PCI
结局指标
主要结局
Reduction in Infarct Size
时间窗: 6 Months
Reduction in infarct size at 6 months as measured by cardiac MRI
次要结局
- MACCE Rates(Through 36 months)
研究者
研究点 (7)
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