COmprehensive Remote Ischemic Conditioning in Myocardial Infarction

NCT ID: NCT03233919

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-01-30

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.

Conditions

Myocardial Infarction, Anterior Wall

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

comprehensive remote ischaemic conditioning

Intervention Type: DEVICE

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.

Non-CORIC

Controls did not undergo comprehensive remote ischaemic conditioning.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

hongbing_yan

Co-Director, Center of cronary artery disease, Fuwai hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hongbing Yan, MD

Role: PRINCIPAL_INVESTIGATOR

National Center for Cardiovascular Diseases

Chinese Academy of Medical Sciences, Fuwai Hospital

Role: PRINCIPAL_INVESTIGATOR

National Center for Cardiovascular Diseases

Locations

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

hongbing yan, MD

Role: CONTACT

bcc_ami@126.com

0086+010 88322281

Li Song, MD

Role: CONTACT

sl9919@126.com

0086+010 88322287

Facility Contacts

Hongbing Yan, MD

Role: primary

bcc_ami@126.com

(0086)10+88322281

Li Song, MD

Role: backup

sl9919@126.com

(0086)10+88322287

Other Identifiers

2017-866

Identifier Type: -

Identifier Source: org_study_id