Clinical trial NCT03233919: COmprehensive Remote Ischemic Conditioning in Myocardial Infarction
Official title: Evaluation of Comprehensive Remote Ischemic Conditioning in ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction, Anterior Wall
Keywords: Remote Ischemic Conditioning
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2017-07-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: left ventricular ejection fraction (LVEF) assessed by CMR
timeFrame: at 30 days after MI
Secondary outcomes:
measure: Infarct size assessed by CMR.
timeFrame: at 30 days after MI
measure: LVEDVi and LVESVi assessed by CMR.
timeFrame: at 30 days after MI
measure: LVEF assessed by echocardiography.
timeFrame: at 30 days, 180 days and 365 days after MI
measure: LVEDVi assessed by echocardiography.
timeFrame: at 30 days, 180 days and 365 days after MI.
measure: The change in LVEDVi assessed by echocardiography.
timeFrame: at 30 days, 180 days and 365 days after MI.
measure: MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke
timeFrame: at 30 days, 180 days and 365 days after MI.
measure: Mean blood N terminal (NT)-PROBNP levels
timeFrame: at 30 days, 180 days and 365 days
measure: TIMI flow and frame count
timeFrame: at the last angiogram during PPCI
measure: ST-segment resolution
timeFrame: on 90 min ECG after reperfusion
measure: the 6-min walk test distance
timeFrame: at 30 days and 180 days after MI
measure: Mean Self-rating Anxiety Scale (SAS) score
timeFrame: at 30 days and 180 days after MI
measure: Mean Self-rating Depression Scale (SDS) score
timeFrame: at 30 days and 180 days after MI.
measure: Mean score of health-related quality of life by using Short-Form 36 Health Survey (SF-36).
timeFrame: at 30 days and 180 days after MI.
Other outcomes:
measure: Contrast-induced nephropathy
timeFrame: at 72 hour and 30 days post-PPCI
measure: Platelet reactivity
timeFrame: at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI.
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences, Fuwai Hospital
state: Beijing
Study officials:
affiliation: National Center for Cardiovascular Diseases
name: hongbing Yan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Cardiovascular Diseases
name: Chinese Academy of Medical Sciences, Fuwai Hospital
role: PRINCIPAL_INVESTIGATOR
References: