Postconditioning in ST-elevation Myocardial Infarction (POSTEMI)
Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI
Study objectives: To assess the effects of postconditioning on infarct size in patients with ST-elevation infarction referred to PCI.
Study design: Prospective, randomized, open-label study with blinded endpoint evaluation. Included patients will be randomly allocated to postconditioning or control. Patients with symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG criteria for primary PCI are eligible. PCI follow established routines. In postconditioning patients, additional, short (1 min), intermittent balloon occlusions will be applied after initial opening of infarct related artery. After this intervention, PCI proceeds routinely with stent implantation. In the control group, stent implantation after initial opening proceeds as usual. Primary endpoint is final infarct size, determined by MRI after 4 months. 260 patients will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months.
Clinical implications: Reperfusion therapy, administered as early as possible after start of symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still, however, many patients suffer large infarctions, subsequently with an increased risk of heart failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has been shown to reduce infarct size and thus potentially improve prognosis. However, the effect of postconditioning must be confirmed in larger clinical trials before implemented in routine treatment.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Oslo、挪威、N-0407
- Dept. of Cardiology, Oslo Univ. Hosp. Ulleval
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- acute symptoms consistent with an acute myocardial infarction of less than 6 hours duration
- an occluded infarct related artery must be demonstrated (TIMI-flow 0-1)
Exclusion Criteria:
- Prior myocardial infarction
- Demonstration of collaterals to the infarcted area
- TIMI-flow >1 before intervention or TIMI-flow <2 after initial balloon inflation
- Demonstration of a distal occlusion
- Patients given thrombolytic treatment
- Patients in cardiogenic shock
- Any contraindication to MRI (magnetic resonance imaging)
- Unwillingness to participate
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Postconditioning
Active arm:Postconditioning protocol before routine PCI/stenting of an occluded coronary artery
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After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
In the postconditioning group 4 additional balloon inflations separated by 1 minute reperfusion are given, starting after 1 minute of reperfusion.
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其他:Control
Control arm: Routine PCI/stenting of an occluded coronary artery without postconditioning
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After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Infarct size, assessed by MRI
大体时间:4 months
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4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Myocardial blushing grade
大体时间:assessed at the end of PCI procedure
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assessed at the end of PCI procedure
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ST-resolution in ECG
大体时间:Assessed after 1 hour
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Assessed after 1 hour
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Troponin-T and CK-MB
大体时间:peak release values
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peak release values
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Echocardiographic evaluation of left ventricular function including speckle-tracking measurement.
大体时间:assessed at baseline, 4 months and1 year
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Assesment of LV function.
Comparison with CMR in the whole study population and between treatment groups.
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assessed at baseline, 4 months and1 year
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Incidence of treated arrhythmias and heart failure during initial hospitalization Incidence of death, non-fatal myocardial infarction, unstable angina, heart failure, and cerebrovascular disease
大体时间:1-year follow up.
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1-year follow up.
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Myocardial salvage
大体时间:Baseline to 4 months
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Myocardial salvage defined as (area at risk-final infarct size)/area at risk.
Area at risk measured by CMR at baseline and final infarct size by CMR at 4 months.
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Baseline to 4 months
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合作者和调查者
调查人员
- 学习椅:Jan Eritsland, MD, PhD、Oslo Univ.Hosp. Ulleval
出版物和有用的链接
一般刊物
- Tollefsen IM, Shetelig C, Seljeflot I, Eritsland J, Hoffmann P, Andersen GO. High levels of interleukin-6 are associated with final infarct size and adverse clinical events in patients with STEMI. Open Heart. 2021 Dec;8(2):e001869. doi: 10.1136/openhrt-2021-001869.
- Limalanathan S, Andersen GO, Klow NE, Abdelnoor M, Hoffmann P, Eritsland J. Effect of ischemic postconditioning on infarct size in patients with ST-elevation myocardial infarction treated by primary PCI results of the POSTEMI (POstconditioning in ST-Elevation Myocardial Infarction) randomized trial. J Am Heart Assoc. 2014 Apr 23;3(2):e000679. doi: 10.1161/JAHA.113.000679.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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