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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CORIC | Experimental | 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. |
|
| Non-CORIC | No Intervention | Controls did not undergo comprehensive remote ischaemic conditioning. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comprehensive remote ischaemic conditioning | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| left ventricular ejection fraction (LVEF) assessed by CMR | LVEF assessed by CMR at 30 days | at 30 days after MI |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-induced nephropathy | Contrast-induced nephropathy at 72 hour and 30 days post-PPCI | at 72 hour and 30 days post-PPCI |
| Platelet reactivity | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hongbing yan, MD | Contact | 0086+010 88322281 | bcc_ami@126.com | |
| Li Song, MD | Contact | 0086+010 88322287 | sl9919@126.com |
| Name | Affiliation | Role |
|---|---|---|
| hongbing Yan, MD | National Center for Cardiovascular Diseases | Principal Investigator |
| Chinese Academy of Medical Sciences, Fuwai Hospital | National Center for Cardiovascular Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D056988 | Anterior Wall Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |
| at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |