NCT03233919

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

April 24, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

July 24, 2017

Last Update Submit

April 20, 2018

Conditions

Myocardial Infarction, Anterior Wall

Keywords

Remote Ischemic Conditioning

Outcome Measures

Primary Outcomes (1)

  • left ventricular ejection fraction (LVEF) assessed by CMR

    LVEF assessed by CMR at 30 days

    at 30 days after MI

Secondary Outcomes (13)

  • Infarct size assessed by CMR.

    at 30 days after MI

  • LVEDVi and LVESVi assessed by CMR.

    at 30 days after MI

  • LVEF assessed by echocardiography.

    at 30 days, 180 days and 365 days after MI

  • LVEDVi assessed by echocardiography.

    at 30 days, 180 days and 365 days after MI.

  • The change in LVEDVi assessed by echocardiography.

    at 30 days, 180 days and 365 days after MI.

  • +8 more secondary outcomes

Other Outcomes (2)

  • Contrast-induced nephropathy

    at 72 hour and 30 days post-PPCI

  • Platelet reactivity

    at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI.

Study Arms (2)

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.

Device: comprehensive remote ischaemic conditioning

Non-CORIC

NO INTERVENTION

Controls did not undergo comprehensive remote ischaemic conditioning.

Interventions

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.

CORIC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Anterior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • hongbing Yan, MD

    National Center for Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    National Center for Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hongbing yan, MD

CONTACT

0086+010 88322281bcc_ami@126.com

Li Song, MD

CONTACT

0086+010 88322287sl9919@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Center of cronary artery disease, Fuwai hospital

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 31, 2017

Study Start

August 1, 2017

Primary Completion

January 30, 2019

Study Completion

January 30, 2020

Last Updated

April 24, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)