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

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ClinicalTrials.gov Identifier: NCT03233919
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
hongbing_yan, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction, Anterior Wall Device: comprehensive remote ischaemic conditioning Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Comprehensive Remote Ischemic Conditioning in ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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.



Primary Outcome Measures :
  1. left ventricular ejection fraction (LVEF) assessed by CMR [ Time Frame: at 30 days after MI ]
    LVEF assessed by CMR at 30 days


Secondary Outcome Measures :
  1. Infarct size assessed by CMR. [ Time Frame: at 30 days after MI ]
    Infarct size assessed by CMR delayed enhancement volume at 30 days.

  2. LVEDVi and LVESVi assessed by CMR. [ Time Frame: at 30 days after MI ]
    LVEDVi and LVESVi assessed by cMRI at 30 days

  3. LVEF assessed by echocardiography. [ Time Frame: at 30 days, 180 days and 365 days after MI ]
    LVEF assessed by echocardiography at 30 days, 180 days and 365 days.

  4. LVEDVi assessed by echocardiography. [ Time Frame: at 30 days, 180 days and 365 days after MI. ]
    LVEDVi assessed by echocardiography at 30 days, 180 days and 365 days.

  5. The change in LVEDVi assessed by echocardiography. [ Time Frame: 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.

  6. MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke [ Time Frame: 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.

  7. Mean blood N terminal (NT)-PROBNP levels [ Time Frame: at 30 days, 180 days and 365 days ]
    Mean blood NT-PROBNP levels at 30 days, 180 days and 365 days.

  8. TIMI flow and frame count [ Time Frame: at the last angiogram during PPCI ]
    TIMI flow and frame count are evaluated at the last angiogram during PPCI.

  9. ST-segment resolution [ Time Frame: on 90 min ECG after reperfusion ]
    ST-segment resolution on 90 min ECG after reperfusion

  10. the 6-min walk test distance [ Time Frame: at 30 days and 180 days after MI ]
    the 6-min walk test distance at 30 days and 180 days after MI.

  11. Mean Self-rating Anxiety Scale (SAS) score [ Time Frame: at 30 days and 180 days after MI ]
    Mean SAS score at 30 days and 180 days after MI.

  12. Mean Self-rating Depression Scale (SDS) score [ Time Frame: at 30 days and 180 days after MI. ]
    Mean SDS score 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). [ Time Frame: 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.


Other Outcome Measures:
  1. Contrast-induced nephropathy [ Time Frame: at 72 hour and 30 days post-PPCI ]
    Contrast-induced nephropathy at 72 hour and 30 days post-PPCI

  2. Platelet reactivity [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233919


Contacts
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Contact: hongbing yan, MD 0086+010 88322281 bcc_ami@126.com
Contact: Li Song, MD 0086+010 88322287 sl9919@126.com

Locations
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China, Beijing
Chinese Academy of Medical Sciences, Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Hongbing Yan, MD    (0086)10+88322281    bcc_ami@126.com   
Contact: Li Song, MD    (0086)10+88322287    sl9919@126.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
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Principal Investigator: hongbing Yan, MD National Center for Cardiovascular Diseases
Principal Investigator: Chinese Academy of Medical Sciences, Fuwai Hospital National Center for Cardiovascular Diseases

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Responsible Party: hongbing_yan, Co-Director, Center of cronary artery disease, Fuwai hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03233919     History of Changes
Other Study ID Numbers: 2017-866
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by hongbing_yan, Chinese Academy of Medical Sciences, Fuwai Hospital:
Remote Ischemic Conditioning
Additional relevant MeSH terms:
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Myocardial Infarction
Anterior Wall Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases