COmprehensive Remote Ischemic Conditioning in Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Comprehensive Remote Ischemic Conditioning in ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Conditions
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Myocardial Infarction, Anterior Wall

Intervention / Treatment
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* Device: comprehensive remote ischaemic conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CORIC<br>Comprehensive remote ischaemic conditioning (CORIC) will be induced using an automated RIC device: Per-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb. The first inflation began immediately following randomization after admission. In case 5 cycles of RIC were not fully completed when the first balloon inflation or thrombus aspiration was ready to be performed, PCI was not to be delayed. Post-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb immediately after PPCI. Delayed-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb once daily on 2-28 days after MI. | Device: comprehensive remote ischaemic conditioning<br>* comprehensive remote ischaemic conditioning will be induced using an automated RIC device: Per-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb. The first inflation began immediately following randomization after admission. In case 5 cycles of RIC were not fully completed when the first balloon inflation or thrombus aspiration was ready to be performed, PCI was not to be delayed. Post-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb immediately after PPCI. Delayed-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb once daily on 2-28 days after MI.<br>|
| No Intervention: Non-CORIC<br>Controls did not undergo comprehensive remote ischaemic conditioning. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection fraction (LVEF) assessed by CMR | LVEF assessed by CMR at 30 days | at 30 days after MI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size assessed by CMR. | Infarct size assessed by CMR delayed enhancement volume at 30 days. | at 30 days after MI | 
| LVEDVi and LVESVi assessed by CMR. | LVEDVi and LVESVi assessed by cMRI at 30 days | at 30 days after MI | 
| LVEF assessed by echocardiography. | LVEF assessed by echocardiography at 30 days, 180 days and 365 days. | at 30 days, 180 days and 365 days after MI | 
| LVEDVi assessed by echocardiography. | LVEDVi assessed by echocardiography at 30 days, 180 days and 365 days. | at 30 days, 180 days and 365 days after MI. | 
| The change in LVEDVi assessed by echocardiography. | The change in LVEDVi assessed by echocardiography from baseline to 30 days, 180 days or 365 days. | at 30 days, 180 days and 365 days after MI. | 
| MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke | MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke at 30 days, 180 days and 365 days. | at 30 days, 180 days and 365 days after MI. | 
| Mean blood N terminal (NT)-PROBNP levels | Mean blood NT-PROBNP levels at 30 days, 180 days and 365 days. | at 30 days, 180 days and 365 days | 
| TIMI flow and frame count | TIMI flow and frame count are evaluated at the last angiogram during PPCI. | at the last angiogram during PPCI | 
| ST-segment resolution | ST-segment resolution on 90 min ECG after reperfusion | on 90 min ECG after reperfusion | 
| the 6-min walk test distance | the 6-min walk test distance at 30 days and 180 days after MI. | at 30 days and 180 days after MI | 
| Mean Self-rating Anxiety Scale (SAS) score | Mean SAS score at 30 days and 180 days after MI. | at 30 days and 180 days after MI | 
| Mean Self-rating Depression Scale (SDS) score | Mean SDS score at 30 days and 180 days after MI. | 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). | The mean score of health-related quality of life by using SF-36 at 30 days and 180 days after MI. | at 30 days and 180 days after MI. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote Ischemic Conditioning