Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 272
- 试验地点
- 2
- 主要终点
- Infarct size, assessed by MRI
研究概览
简要总结
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)
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
- •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)
排除标准
- •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
结局指标
主要结局
Infarct size, assessed by MRI
时间窗: 4 months
次要结局
- Myocardial blushing grade(assessed at the end of PCI procedure)
- Troponin-T and CK-MB(peak release values)
- ST-resolution in ECG(Assessed after 1 hour)
- Echocardiographic evaluation of left ventricular function including speckle-tracking measurement.(assessed at baseline, 4 months and1 year)
- Incidence of treated arrhythmias and heart failure during initial hospitalization Incidence of death, non-fatal myocardial infarction, unstable angina, heart failure, and cerebrovascular disease(1-year follow up.)
- Myocardial salvage(Baseline to 4 months)
研究者
Jan Eritsland
Senior Consultant Cardiology
Oslo University Hospital