Myocardial Infarction, Anterior Wall
Conditions
Keywords
Remote Ischemic Conditioning
Brief summary
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
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.
Interventions
DEVICEcomprehensive remote ischaemic conditioning
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.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular ejection fraction (LVEF) assessed by CMR | at 30 days after MI | LVEF assessed by CMR at 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Self-rating Depression Scale (SDS) score | at 30 days and 180 days after MI. | Mean SDS score at 30 days and 180 days after MI. |
| Mean Self-rating Anxiety Scale (SAS) score | at 30 days and 180 days after MI | Mean SAS score at 30 days and 180 days after MI. |
| Infarct size assessed by CMR. | at 30 days after MI | Infarct size assessed by CMR delayed enhancement volume at 30 days. |
| LVEDVi and LVESVi assessed by CMR. | at 30 days after MI | LVEDVi and LVESVi assessed by cMRI at 30 days |
| LVEF assessed by echocardiography. | at 30 days, 180 days and 365 days after MI | LVEF assessed by echocardiography at 30 days, 180 days and 365 days. |
| LVEDVi assessed by echocardiography. | at 30 days, 180 days and 365 days after MI. | LVEDVi assessed by echocardiography at 30 days, 180 days and 365 days. |
| The change in LVEDVi assessed by echocardiography. | at 30 days, 180 days and 365 days after MI. | The change in LVEDVi assessed by echocardiography from baseline to 30 days, 180 days or 365 days. |
| the 6-min walk test distance | at 30 days and 180 days after MI | the 6-min walk test distance 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. | The mean score of health-related quality of life by using SF-36 at 30 days and 180 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. | MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke at 30 days, 180 days and 365 days. |
| Mean blood N terminal (NT)-PROBNP levels | at 30 days, 180 days and 365 days | Mean blood NT-PROBNP levels at 30 days, 180 days and 365 days. |
| TIMI flow and frame count | at the last angiogram during PPCI | TIMI flow and frame count are evaluated at the last angiogram during PPCI. |
| ST-segment resolution | on 90 min ECG after reperfusion | ST-segment resolution on 90 min ECG after reperfusion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Contrast-induced nephropathy | at 72 hour and 30 days post-PPCI | Contrast-induced nephropathy at 72 hour and 30 days post-PPCI |
| Platelet reactivity | at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI. | Platelet reactivity assessed by VerifyNow P2Y12 assay at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI. |
Countries
China
Contacts
Primary Contacthongbing yan, MD
Backup ContactLi Song, MD
Outcome results
None listed