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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Remote Ischemic Conditioning in STEMI to Decrease Infarct Size

Clinicaltrials.gov identifier NCT03930589

Recruitment Status Completed

First Posted April 29, 2019

Last update posted April 29, 2019

Study Description

Brief summary:

Following acute STEMI patients may have significant myocardial damage and subsequent heart failure. There is currently conflicting data regarding the benefit of remote ischemic conditioning to decrease the magnitude of infarction. Remote ischemic condition is a process where by repetitive intermittent limb ischemia is used to decrease the magnitude of myocardial damage caused by coronary artery occlusion and the subsequent reperfusion injury in STEMI patients. RemCon-STEMI is a multicenter randomized trial to test the impact of remote ischemic conditioning in acute STEMI.

  • Condition or Disease:STEMI
  • Intervention/Treatment: Procedure: Remote Ischemic conditioning
    Other: Standard of care
  • Phase: N/A
Detailed Description


Study Design
  • Study Type: Interventional
  • Actual Enrollment: 251 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Remote ischemic condition versus standard of care
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Multi-center Randomized Trial of Remote Ischemic Conditioning to Reduce Infarct Size in Patients With an ST-Elevation Myocardial Infarction
  • Actual Study Start Date: November 2013
  • Actual Primary Completion Date: August 2017
  • Actual Study Completion Date: November 2018
Arms and interventions
Arm Intervention/treatment
Active Comparator: Remote Ischemic Conditioning
Remote ischemic conditioning using BP cuff on left arm
Procedure: Remote Ischemic conditioning
BP cuff inflation for 5 min and deflation for 5 mins with 4 cycles
Placebo Comparator: Standard of care
no intervention will occur in the standard of care arm
Other: Standard of care
Standard of care
Outcome Measures
  • Primary Outcome Measures: 1. Composite of all cause death [ Time Frame: 90 days ]
    all cause death, cardiogenic shock or chf through 90 days
  • Secondary Outcome Measures: 1. long term survival [ Time Frame: up to 1 year ]
  • 2. myocardial infarction size [ Time Frame: within 72 hours of hospital admission ]
    mi size using peak elevation of cardiac biomarkers
  • 3. ECG infarct size [ Time Frame: with 10 days or hospital discharge whichever occurs first ]
    QRS score on baseline and discharge ECGS
  • 4. Reperfusion [ Time Frame: within 24 hours of admission to hospital ]
    ST segment resolution 30 minutes post PCI
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients presenting with STEMI within 6 hours of symptom onset and:

1. Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI.

2. Documented informed consent (verbal)

Exclusion Criteria:

1. Cardiogenic shock

2. History of anatomical deformity or vascular complication that limit ability to conduct
remote ischemic preconditioning

Contacts and Locations
Sponsors and Collaborators

University of Alberta

Canadian VIGOUR Centre

More Information
  • Responsible Party: University of Alberta
  • ClinicalTrials.gov Identifier: NCT03930589 History of Changes
  • Other Study ID Numbers: V1 November 15, 2013
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: April 29, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: ST Elevation Myocardial Infarction