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

Primary Purpose

Myocardial Infarction, Anterior Wall

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
comprehensive remote ischaemic conditioning
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction, Anterior Wall focused on measuring Remote Ischemic Conditioning

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese Academy of Medical Sciences, Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CORIC

Non-CORIC

Arm Description

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.

Controls did not undergo comprehensive remote ischaemic conditioning.

Outcomes

Primary Outcome Measures

left ventricular ejection fraction (LVEF) assessed by CMR
LVEF assessed by CMR at 30 days

Secondary Outcome Measures

Infarct size assessed by CMR.
Infarct size assessed by CMR delayed enhancement volume at 30 days.
LVEDVi and LVESVi assessed by CMR.
LVEDVi and LVESVi assessed by cMRI at 30 days
LVEF assessed by echocardiography.
LVEF assessed by echocardiography at 30 days, 180 days and 365 days.
LVEDVi assessed by echocardiography.
LVEDVi assessed by echocardiography at 30 days, 180 days and 365 days.
The change in LVEDVi assessed by echocardiography.
The change in LVEDVi assessed by echocardiography from baseline to 30 days, 180 days or 365 days.
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.
Mean blood N terminal (NT)-PROBNP levels
Mean blood NT-PROBNP levels 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.
ST-segment resolution
ST-segment resolution 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.
Mean Self-rating Anxiety Scale (SAS) score
Mean SAS score 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.
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.

Full Information

First Posted
July 24, 2017
Last Updated
April 20, 2018
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT03233919
Brief Title
COmprehensive Remote Ischemic Conditioning in Myocardial Infarction
Acronym
CORIC-MI
Official Title
Evaluation of Comprehensive Remote Ischemic Conditioning in ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Anterior Wall
Keywords
Remote Ischemic Conditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CORIC
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-CORIC
Arm Type
No Intervention
Arm Description
Controls did not undergo comprehensive remote ischaemic conditioning.
Intervention Type
Device
Intervention Name(s)
comprehensive remote ischaemic conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
left ventricular ejection fraction (LVEF) assessed by CMR
Description
LVEF assessed by CMR at 30 days
Time Frame
at 30 days after MI
Secondary Outcome Measure Information:
Title
Infarct size assessed by CMR.
Description
Infarct size assessed by CMR delayed enhancement volume at 30 days.
Time Frame
at 30 days after MI
Title
LVEDVi and LVESVi assessed by CMR.
Description
LVEDVi and LVESVi assessed by cMRI at 30 days
Time Frame
at 30 days after MI
Title
LVEF assessed by echocardiography.
Description
LVEF assessed by echocardiography at 30 days, 180 days and 365 days.
Time Frame
at 30 days, 180 days and 365 days after MI
Title
LVEDVi assessed by echocardiography.
Description
LVEDVi assessed by echocardiography at 30 days, 180 days and 365 days.
Time Frame
at 30 days, 180 days and 365 days after MI.
Title
The change in LVEDVi assessed by echocardiography.
Description
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.
Title
MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke
Description
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.
Title
Mean blood N terminal (NT)-PROBNP levels
Description
Mean blood NT-PROBNP levels at 30 days, 180 days and 365 days.
Time Frame
at 30 days, 180 days and 365 days
Title
TIMI flow and frame count
Description
TIMI flow and frame count are evaluated at the last angiogram during PPCI.
Time Frame
at the last angiogram during PPCI
Title
ST-segment resolution
Description
ST-segment resolution on 90 min ECG after reperfusion
Time Frame
on 90 min ECG after reperfusion
Title
the 6-min walk test distance
Description
the 6-min walk test distance at 30 days and 180 days after MI.
Time Frame
at 30 days and 180 days after MI
Title
Mean Self-rating Anxiety Scale (SAS) score
Description
Mean SAS score at 30 days and 180 days after MI.
Time Frame
at 30 days and 180 days after MI
Title
Mean Self-rating Depression Scale (SDS) score
Description
Mean SDS score at 30 days and 180 days after MI.
Time Frame
at 30 days and 180 days after MI.
Title
Mean score of health-related quality of life by using Short-Form 36 Health Survey (SF-36).
Description
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 Pre-specified Outcome Measures:
Title
Contrast-induced nephropathy
Description
Contrast-induced nephropathy at 72 hour and 30 days post-PPCI
Time Frame
at 72 hour and 30 days post-PPCI
Title
Platelet reactivity
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hongbing yan, MD
Phone
0086+010 88322281
Email
bcc_ami@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Song, MD
Phone
0086+010 88322287
Email
sl9919@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hongbing Yan, MD
Organizational Affiliation
National Center for Cardiovascular Diseases
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chinese Academy of Medical Sciences, Fuwai Hospital
Organizational Affiliation
National Center for Cardiovascular Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences, Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbing Yan, MD
Phone
(0086)10+88322281
Email
bcc_ami@126.com
First Name & Middle Initial & Last Name & Degree
Li Song, MD
Phone
(0086)10+88322287
Email
sl9919@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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COmprehensive Remote Ischemic Conditioning in Myocardial Infarction

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