A Multi-center Randomized Trial of Remote Ischemic Conditioning to Reduce Infarct Size in Patients With an ST-Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 主要终点
- Composite of all cause death
研究概览
简要总结
Following acute STEMI patients may have significant myocardial damage and subsequent heart failure. There is currently conflicting data regarding the benefit of remote ischemic conditioning to decrease the magnitude of infarction. Remote ischemic condition is a process where by repetitive intermittent limb ischemia is used to decrease the magnitude of myocardial damage caused by coronary artery occlusion and the subsequent reperfusion injury in STEMI patients. RemCon-STEMI is a multicenter randomized trial to test the impact of remote ischemic conditioning in acute STEMI.
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)
盲法说明
Patient outcomes and markers blinded to randomization arm
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with STEMI within 6 hours of symptom onset and:
- •Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI.
- •Documented informed consent (verbal)
排除标准
- •Cardiogenic shock
- •History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning
研究组 & 干预措施
Standard of care
no intervention will occur in the standard of care arm
干预措施: Standard of care (Other)
Remote Ischemic Conditioning
Remote ischemic conditioning using BP cuff on left arm
干预措施: Remote Ischemic conditioning (Procedure)
结局指标
主要结局
Composite of all cause death
时间窗: 90 days
all cause death, cardiogenic shock or chf through 90 days
次要结局
- long term survival(up to 1 year)
- myocardial infarction size(within 72 hours of hospital admission)
- ECG infarct size(with 10 days or hospital discharge whichever occurs first)
- Reperfusion(within 24 hours of admission to hospital)
研究者
Robert Welsh
Professor
University of Alberta