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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
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.
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, China
RECRUITINGleft ventricular ejection fraction (LVEF) assessed by CMR
LVEF assessed by CMR at 30 days
Time frame: at 30 days after MI
Infarct size assessed by CMR.
Infarct size assessed by CMR delayed enhancement volume at 30 days.
Time frame: at 30 days after MI
LVEDVi and LVESVi assessed by CMR.
LVEDVi and LVESVi assessed by cMRI at 30 days
Time frame: at 30 days after MI
LVEF assessed by echocardiography.
LVEF assessed by echocardiography at 30 days, 180 days and 365 days.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at 30 days, 180 days and 365 days after MI.
Mean blood N terminal (NT)-PROBNP levels
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Mean blood NT-PROBNP levels at 30 days, 180 days and 365 days.
Time frame: 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.
Time frame: at the last angiogram during PPCI
ST-segment resolution
ST-segment resolution on 90 min ECG after reperfusion
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at 30 days and 180 days after MI.