Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance
研究概览
简要总结
- Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI.
- Trial Design: Placebo controlled randomized study with parallel groups
- Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7
- Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months.
- Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
- Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180.
- Safety Parameters: Major adverse cardiovascular events.
详细描述
See above. 3 patients left to include.
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
- •Patient planned for primary PCI.
- •Chest pain indicating myocardial ischemia with a duration >30 minutes and < 6 hours prior to randomization.
- •ST elevations >0.1 mV (>0.2 mV in V2-V3) in > two contiguous leads in V1-V
- •Informed consent.
排除标准
- •Previous myocardial infarction based on medical history or Q-wave on ECG in other area
- •Left Bundle Branch Block on ECG.
- •Previous CABG
- •Cardiac arrest
- •Any contraindication for CMR.
- •Clinical symptoms of claudication
- •Treatment with glibenclamide or cyclosporine on admission.
- •Any condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
研究组 & 干预措施
Remote Ischemic per-postconditioning
Remote conditioning is induced by inflation of a blood pressure cuff around the left thigh to 200 mmHg or 20 mmHg above systolic blood pressure (if >180 mmHg) for 5 min followed by deflation for 5 min. At least one of these conditioning cycles is performed before PCI is initiated. If time allows, cycles of remote conditioning (5 min leg ischemia and 5 min reperfusion) are repeated until PCI is performed. Following reperfusion, defined as first balloon inflation, four additional cycles of remote conditioning will be performed.
干预措施: Primary Percutaneous Coronary Intervention (Procedure)
Sham
The sham procedures include application of the cuff around the thigh but it is not inflated.
Otheriwize normal primary PCI.
干预措施: Primary Percutaneous Coronary Intervention (Procedure)
结局指标
主要结局
Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance
时间窗: 4-7 days following index event
次要结局
- Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance(6 months following index event)
研究者
John Pernow
Professor
Karolinska Institutet