Evaluation of Comprehensive Remote Ischemic Conditioning in ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- left ventricular ejection fraction (LVEF) assessed by CMR
研究概览
简要总结
The primary objective of the CORIC-MI trial is to evaluate whether comprehensive (per, post plus delayed) remote ischemic conditioning (CORIC) as an adjunctive therapy in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) can improve left ventricular function and remodeling at 30 days assessed by cardiac magnetic resonance imaging (CMR) for a minimum follow-up period of 12 months.
详细描述
ST-segment elevation myocardial infarction (STEMI) is a leading cause of mortality and morbidity worldwide. Rapid admission and acute interventional treatment combined with modern antithrombotic pharmacologic therapy frequently establish complete reperfusion and acutely stabilize the patient, but the reperfusion itself adds further to the damage in the myocardium compromising the long-term outcome. At present, remote ischemic conditioning (RIC) is the most promising adjuvant therapy to reduce reperfusion injury in patients with STEMI. However, myocardial remodeling continues for several weeks after a myocardial infarction. Recent animal studies have shown that RIC may also help the heart muscle recover if applied every day during the month after a heart attack.
The CORIC-MI trial is a single-center, randomized, controlled, parallel group, and open-label trial, with blinded evaluation of the endpoints.The primary objective of the trial is to evaluate whether comprehensive (per, post plus delayed) remote ischemic conditioning (CORIC) as an adjunctive therapy in patients with STEMI undergoing primary percutaneous coronary intervention (PPCI) can improve left ventricular function and remodeling at 30 days assessed by cardiac magnetic resonance imaging (CMR) for a minimum follow-up period of 12 months.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected anterior STEMI: new ST-elevation > 0.1 millivolt (mV) (≥ 0.2 mV in men or ≥ 0.15 mV in women in leads V2-V3) in > two contiguous leads in V1-V6; new or presumed new left bundle branch block;
- •Symptom onset no more than 12 h before presentation and planned primary PCI;
- •Age 18 to 75 years;
- •Willingness and capability to provide informed consent.
排除标准
- •Previous anterior myocardial infarction;
- •Previous coronary artery bypass graft (CABG);
- •Myocardial infarction or stroke within the previous 30 days;
- •Treatment with thrombolysis within the previous 30 days;
- •Cardiogenic shock;
- •Thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3 at coronary angiography;
- •Coronary anatomy or mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation) warranting emergent surgery;
- •Inability to obtain TIMI flow grade ≥ 2;
- •Conditions precluding use of RIC (paresis of lower limb, known severe peripheral artery disease or evidence of lower limb ischemia, and etc.);
- •Life expectancy of less than 12 months due to non-cardiac disease such as known malignancy or other comorbid conditions;
- •Contraindications to CMR;
- •Treated with therapeutic hypothermia before admission;
- •Pregnancy and lactating women;
- •Participation in another interventional trial.
结局指标
主要结局
left ventricular ejection fraction (LVEF) assessed by CMR
时间窗: at 30 days after MI
LVEF assessed by CMR at 30 days
次要结局
- LVEF assessed by echocardiography.(at 30 days, 180 days and 365 days after MI)
- Mean blood N terminal (NT)-PROBNP levels(at 30 days, 180 days and 365 days)
- Infarct size assessed by CMR.(at 30 days after MI)
- The change in LVEDVi assessed by echocardiography.(at 30 days, 180 days and 365 days after MI.)
- MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke(at 30 days, 180 days and 365 days after MI.)
- ST-segment resolution(on 90 min ECG after reperfusion)
- LVEDVi assessed by echocardiography.(at 30 days, 180 days and 365 days after MI.)
- TIMI flow and frame count(at the last angiogram during PPCI)
- the 6-min walk test distance(at 30 days and 180 days after MI)
- LVEDVi and LVESVi assessed by CMR.(at 30 days after MI)
- Mean Self-rating Anxiety Scale (SAS) score(at 30 days and 180 days after MI)
- Mean score of health-related quality of life by using Short-Form 36 Health Survey (SF-36).(at 30 days and 180 days after MI.)
- Mean Self-rating Depression Scale (SDS) score(at 30 days and 180 days after MI.)
研究者
hongbing_yan
Co-Director, Center of cronary artery disease, Fuwai hospital
Chinese Academy of Medical Sciences, Fuwai Hospital