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Remote Ischemic Conditioning in STEMI to Decrease Infarct Size (RemCon-STEMI)

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ClinicalTrials.gov Identifier: NCT03930589
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Canadian VIGOUR Centre
Information provided by (Responsible Party):
Robert Welsh, University of Alberta

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 Intervention/treatment Phase
STEMI CAD Procedure: Remote Ischemic conditioning Other: Standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Remote ischemic condition versus standard of care
Masking: Single (Outcomes Assessor)
Masking Description: Patient outcomes and markers blinded to randomization arm
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 8, 2013
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : November 26, 2018

Arm Intervention/treatment
Placebo Comparator: Standard of care
no intervention will occur in the standard of care arm
Other: Standard of care
Standard of care

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




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 ]
    survival

  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Robert Welsh, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03930589    
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 Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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ST Elevation Myocardial Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases