COmprehensive Remote Ischemic Conditioning in Myocardial Infarction (CORIC-MI)

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

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.

Study Overview

• Status: Unknown
• Conditions: Myocardial Infarction, Anterior Wall
• Intervention / Treatment: Device: comprehensive remote ischaemic conditioning

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Chinese Academy of Medical Sciences, Fuwai Hospital
      • Contact: Li Song, MD; Phone Number: (0086)10+88322287; Email: sl9919@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CORIC; 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; 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.
NO_INTERVENTION: Non-CORIC; Controls did not undergo comprehensive remote ischaemic conditioning.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	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.	at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI.

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: hongbing Yan, MD, National Center for Cardiovascular Diseases; Principal Investigator: Chinese Academy of Medical Sciences, Fuwai Hospital, National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ANTICIPATED): January 30, 2019
• Study Completion (ANTICIPATED): January 30, 2020

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (ACTUAL): July 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Remote Ischemic Conditioning
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Anterior Wall Myocardial Infarction
• Other Study ID Numbers: 2017-866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No