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

April 20, 2018 updated by: hongbing_yan, China National Center for Cardiovascular Diseases

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: hongbing yan, MD
  • Phone Number: 0086+010 88322281
  • Email: bcc_ami@126.com

Study Contact Backup

  • Name: Li Song, MD
  • Phone Number: 0086+010 88322287
  • Email: sl9919@126.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Chinese Academy of Medical Sciences, Fuwai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
left ventricular ejection fraction (LVEF) assessed by CMR
Time Frame: at 30 days after MI
LVEF assessed by CMR at 30 days
at 30 days after MI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infarct size assessed by CMR.
Time Frame: at 30 days after MI
Infarct size assessed by CMR delayed enhancement volume at 30 days.
at 30 days after MI
LVEDVi and LVESVi assessed by CMR.
Time Frame: at 30 days after MI
LVEDVi and LVESVi assessed by cMRI at 30 days
at 30 days after MI
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.
at 30 days, 180 days and 365 days after MI
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.
at 30 days, 180 days and 365 days after MI.
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.
at 30 days, 180 days and 365 days after MI.
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.
at 30 days, 180 days and 365 days after MI.
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.
at 30 days, 180 days and 365 days
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.
at the last angiogram during PPCI
ST-segment resolution
Time Frame: on 90 min ECG after reperfusion
ST-segment resolution on 90 min ECG after reperfusion
on 90 min ECG after reperfusion
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.
at 30 days and 180 days after MI
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.
at 30 days and 180 days after MI
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.
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).
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.
at 30 days and 180 days after MI.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contrast-induced nephropathy
Time Frame: at 72 hour and 30 days post-PPCI
Contrast-induced nephropathy at 72 hour and 30 days post-PPCI
at 72 hour and 30 days post-PPCI
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.
at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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