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Status unknownNCT03233919CORIC-MIUpdated Apr 24, 2018

COmprehensive Remote Ischemic Conditioning in Myocardial Infarction

An interventional study of comprehensive remote ischaemic conditioning in Myocardial Infarction, Anterior Wall, sponsored by China National Center for Cardiovascular Diseases. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-24.

Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Myocardial Infarction, Anterior Wall

Keywords

  • Remote Ischemic Conditioning
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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 200 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • No intervention
    Non-CORIC

    Controls did not undergo comprehensive remote ischaemic conditioning.

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.

06

What researchers measure

Primary outcomes

  1. left ventricular ejection fraction (LVEF) assessed by CMR

    LVEF assessed by CMR at 30 days

    Time frame: at 30 days after MI

Secondary outcomes

  1. Infarct size assessed by CMR.

    Infarct size assessed by CMR delayed enhancement volume at 30 days.

    Time frame: at 30 days after MI

  2. LVEDVi and LVESVi assessed by CMR.

    LVEDVi and LVESVi assessed by cMRI at 30 days

    Time frame: at 30 days after MI

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. Mean blood N terminal (NT)-PROBNP levels

    Mean blood NT-PROBNP levels at 30 days, 180 days and 365 days.

    Time frame: at 30 days, 180 days and 365 days

  8. 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

  9. ST-segment resolution

    ST-segment resolution on 90 min ECG after reperfusion

    Time frame: on 90 min ECG after reperfusion

  10. 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

  11. 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

  12. 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.

  13. 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.

Other outcomes

  1. Contrast-induced nephropathy

    Contrast-induced nephropathy at 72 hour and 30 days post-PPCI

    Time frame: at 72 hour and 30 days post-PPCI

  2. 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.

    Time frame: at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI.

07

Study locations

1 of 1 sites recruiting
  • Chinese Academy of Medical Sciences, Fuwai Hospital
    Beijing, Beijing 100037, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03233919
Lead sponsor
China National Center for Cardiovascular Diseases
Responsible party
hongbing_yan (Co-Director, Center of cronary artery disease, Fuwai hospital, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Jul 31, 2017
Start date
Aug 1, 2017
Primary completion
Jan 30, 2019 (estimated)
Completion
Jan 30, 2020 (estimated)
Last update
Apr 24, 2018

Study contacts

hongbing yan, MD
Contact
bcc_ami@126.com
0086+010 88322281
Li Song, MD
Contact
sl9919@126.com
0086+010 88322287
hongbing Yan, MD
principal investigator · National Center for Cardiovascular Diseases
Chinese Academy of Medical Sciences, Fuwai Hospital
principal investigator · National Center for Cardiovascular Diseases

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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