Myocardial Infarction, Anterior WallCORIC-MINCT03233919
COmprehensive Remote Ischemic Conditioning in Myocardial Infarction
A study testing comprehensive remote ischaemic conditioning in people with Myocardial Infarction, Anterior Wall, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Anterior Wall
- What is being tested?
- comprehensive remote ischaemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, 100037
Hongbing Yan, MD, (0086)10+88322281, bcc_ami@126.com
Li Song, MD, (0086)10+88322287, sl9919@126.com
About this study
Official title: 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.
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.
- Conditions
- Myocardial Infarction, Anterior Wall
- Being tested
- comprehensive remote ischaemic conditioning
- Keywords
- Remote Ischemic Conditioning
- Medical subject headings
- Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive remote ischaemic conditioningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CORIC | Experimental | 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. Receives: Device: comprehensive remote ischaemic conditioning |
| Non-CORIC | No intervention | Controls did not undergo comprehensive remote ischaemic conditioning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular ejection fraction (LVEF) assessed by CMR
LVEF assessed by CMR at 30 days
Measured: at 30 days after MI
Secondary outcomes (13)
Infarct size assessed by CMR.
Infarct size assessed by CMR delayed enhancement volume at 30 days.
Measured: at 30 days after MI
LVEDVi and LVESVi assessed by CMR.
LVEDVi and LVESVi assessed by cMRI at 30 days
Measured: at 30 days after MI
LVEF assessed by echocardiography.
LVEF assessed by echocardiography at 30 days, 180 days and 365 days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at the last angiogram during PPCI
ST-segment resolution
ST-segment resolution on 90 min ECG after reperfusion
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 30 days and 180 days after MI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Jan 2019 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, Anterior WallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, hongbing_yan, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- hongbing Yan, MD, Principal investigator, National Center for Cardiovascular DiseasesChinese Academy of Medical Sciences, Fuwai Hospital, Principal investigator, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233919
- Sponsor's protocol ID
- 2017-866
- Acronym
- CORIC-MI
- Status last verified
- Mar 2018
- First submitted
- 24 Jul 2017
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Comprehensive Remote Ischemic Conditioning in ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03233919
- Acronym / sponsor ID
- CORIC-MI / 2017-866
- Conditions
- Myocardial Infarction, Anterior Wall
- Keywords
- Remote Ischemic Conditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CORIC | Experimental | Device: comprehensive remote ischaemic conditioningComprehensive 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. |
| Non-CORIC | No intervention | –Controls did not undergo comprehensive remote ischaemic conditioning. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive remote ischaemic conditioningcomprehensive 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. | Device | CORIC |
Primary outcome
left ventricular ejection fraction (LVEF) assessed by CMR
Time frame: at 30 days after MI
LVEF assessed by CMR at 30 days
13 secondary outcomes
Infarct size assessed by CMR.
Time frame: at 30 days after MI
LVEDVi and LVESVi assessed by CMR.
Time frame: at 30 days after MI
LVEF assessed by echocardiography.
Time frame: 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.
The change in LVEDVi assessed by echocardiography.
Time frame: 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.
Mean blood N terminal (NT)-PROBNP levels
Time frame: at 30 days, 180 days and 365 days
TIMI flow and frame count
Time frame: at the last angiogram during PPCI
ST-segment resolution
Time frame: on 90 min ECG after reperfusion
the 6-min walk test distance
Time frame: 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 Self-rating Depression Scale (SDS) score
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hongbing Yan, MD principal investigator
National Center for Cardiovascular Diseases
Chinese Academy of Medical Sciences, Fuwai Hospital principal investigator
National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive remote ischaemic conditioning in people with Myocardial Infarction, Anterior Wall, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hongbing yan, MD (0086+010 88322281, bcc_ami@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular ejection fraction (LVEF) assessed by CMR (time frame: at 30 days after MI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.