NCT00942500已完成不适用
Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- The dichotomous rate of complete ST-segment resolution (STR)
研究概览
简要总结
The purpose of this study is to investigate the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction.
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
- None
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
- •General Inclusion Criteria
- •Subject must be at least 18 years of age.
- •Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving postconditioning and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
- •Diagnosis of STEMI
- •presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
- •ST-segment elevation more than 1 mm in at least 2 contiguous leads
- •Angiographic Inclusion Criteria
- •Target lesion(s) must be located in a native coronary artery
- •Target lesion(s) must be amenable for percutaneous coronary intervention
- •TIMI flow grade of infarct related arteries <2
排除标准
- •Patients with hemodynamic instability or those with cardiogenic shock
- •Target lesion is located in left main stem
- •Rescue PCI after thrombolysis or facilitated PCI
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
研究组 & 干预措施
Post-conditioning
Experimental
干预措施: Post-conditioning (Procedure)
Conventional primary PCI
No Intervention
结局指标
主要结局
The dichotomous rate of complete ST-segment resolution (STR)
时间窗: at 30 minutes after final contrast injection
次要结局
- Myocardial blush grade(within 10 minutes after PCI)
- Thrombolysis in Myocardial Infarction (TIMI) flow grade(within 10 minutes after PCI)
- Angiographic no-reflow(during PCI)
- All death(at 30 days and 1 year)
- Stent thrombosis(at 30 days and 1 year)
- Cardiac death(at 30 days and 1 year)
- Myocardial infarction(at 30 days and 1 year)
- Severe heart failure(at 30 days and 1 year)
- Target vessel revascularization (TVR)(at 30 days and 1 year)
- Composite of death, MI, severe heart failure, or stent thrombosis(at 30 days and 1 year)
研究者
Hyeon-Cheol Gwon
Professor
Samsung Medical Center
研究点 (1)
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