NCT00833612已完成4 期
A Multi-center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 77
- 主要终点
- To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.
研究概览
简要总结
Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.
详细描述
Post clearance device study in which subjects with acute MI will be randomized 1:1 to either receive IAB or to receive standard of care without IAB before mechanical reperfusion. Subjects will be followed throughout their hospital stay and at 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign an ICF
- •≥ 18 and ≤ 90 years of age
- •General good health, in the opinion of the investigator
- •ST elevation of 2mm in 2 contiguous anterior leads or ≥ 4mm total in anterior leads
- •Scheduled for PCI < 6 hours from onset of symptoms of MI
排除标准
- •Known contraindication to MRI
- •Prior thrombolytic therapy during the index event
- •Known history of MI
- •Known severe aortic insufficiency
- •Known aortic aneurysm
- •Known severe calcific aorta-iliac disease or peripheral vascular disease
- •Experiencing cardiac shock
- •Known end-stage renal disease
- •Weight >400 lbs. or height <4 ft.
结局指标
主要结局
To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.
时间窗: 3-5 days
次要结局
- To determine the effect of IABC before mechanical reperfusion on post PCI cardiovascular function and major adverse cardiac events (MACE) (ie, death, reinfarction, and CHF) at 30 days and 6 months.(30 days and 6 months post randomization)
研究者
研究点 (77)
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