Effect of Remote Ischaemic Conditioning on Clinical Outcomes in ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention (CONDI2/ERIC-PPCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,413
- 试验地点
- 35
- 主要终点
- Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.
研究概览
简要总结
The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure at 12 months in patients presenting with a ST-elevation myocardial infarction and treated by percutaneous coronary intervention.
详细描述
The CONDI2/ERIC-PPCI trial is a randomised controlled clinical trial investigating whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in 5400 patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI).
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Onset of STEMI symptoms within 12 hours, lasting for more than 30 minutes
- •Patients older than 18 years
- •Suspected STEMI (ST-elevation at the J-point in two contiguous leads with the cutoff points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads)
排除标准
- •Previous coronary artery bypass graft surgery
- •Myocardial infarction within the previous 30 days
- •Treatment with thrombolysis within the previous 30 days
- •Left bundle branch block
- •Patients treated with therapeutic hypothermia
- •Conditions precluding use of RIC (paresis of upper limb, use of an a-v shunt)
- •Life expectancy of less than 1 year due to non-cardiac pathology
研究组 & 干预措施
Remote ischemic conditioning
AutoRIC device will be placed on the upper arm and an active RIC protocol will be delivered (4x5 min cycles of inflation to 200mmHg and deflation) prior to PPCI.
干预措施: Remote ischemic conditioning (Device)
Sham control
Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI.
干预措施: Control (Device)
结局指标
主要结局
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.
时间窗: One year
次要结局
- Rates of cardiac death and HHF at 30 days.(30 days)
- Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.(12 months)
- TIMI flow post-PPCI.(1 week)
- Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).(One year)
- Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers(1 week)
- CMR substudy: Cardiac MRI in first week and at 6 months(6 months)