Back to resultsRemote Ischemic Conditioning in STEMI to Decrease Infarct Size (RemCon-STEMI)
Primary Purpose
STEMI, CAD
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote Ischemic conditioning
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for STEMI
Eligibility Criteria
Inclusion Criteria:
Patients presenting with STEMI within 6 hours of symptom onset and:
- Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI.
- Documented informed consent (verbal)
Exclusion Criteria:
- Cardiogenic shock
- History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Standard of care
Remote Ischemic Conditioning
Arm Description
no intervention will occur in the standard of care arm
Remote ischemic conditioning using BP cuff on left arm
Outcomes
Primary Outcome Measures
Composite of all cause death
all cause death, cardiogenic shock or chf through 90 days
Secondary Outcome Measures
long term survival
survival
myocardial infarction size
mi size using peak elevation of cardiac biomarkers
ECG infarct size
QRS score on baseline and discharge ECGS
Reperfusion
ST segment resolution 30 minutes post PCI
Full Information
NCT ID
NCT03930589
First Posted
April 30, 2018
Last Updated
April 25, 2019
Sponsor
University of Alberta
Collaborators
Canadian VIGOUR Centre
1. Study Identification
Unique Protocol Identification Number
NCT03930589
Brief Title
Remote Ischemic Conditioning in STEMI to Decrease Infarct Size
Acronym
RemCon-STEMI
Official Title
A Multi-center Randomized Trial of Remote Ischemic Conditioning to Reduce Infarct Size in Patients With an ST-Elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2013 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
November 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
Canadian VIGOUR Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI, CAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Remote ischemic condition versus standard of care
Masking
Outcomes Assessor
Masking Description
Patient outcomes and markers blinded to randomization arm
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Placebo Comparator
Arm Description
no intervention will occur in the standard of care arm
Arm Title
Remote Ischemic Conditioning
Arm Type
Active Comparator
Arm Description
Remote ischemic conditioning using BP cuff on left arm
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic conditioning
Intervention Description
BP cuff inflation for 5 min and deflation for 5 mins with 4 cycles
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Composite of all cause death
Description
all cause death, cardiogenic shock or chf through 90 days
Time Frame
90 days
Secondary Outcome Measure Information:
Title
long term survival
Description
survival
Time Frame
up to 1 year
Title
myocardial infarction size
Description
mi size using peak elevation of cardiac biomarkers
Time Frame
within 72 hours of hospital admission
Title
ECG infarct size
Description
QRS score on baseline and discharge ECGS
Time Frame
with 10 days or hospital discharge whichever occurs first
Title
Reperfusion
Description
ST segment resolution 30 minutes post PCI
Time Frame
within 24 hours of admission to hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting with STEMI within 6 hours of symptom onset and:
Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI.
Documented informed consent (verbal)
Exclusion Criteria:
Cardiogenic shock
History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34417205
Citation
Bainey KR, Zheng Y, Coulden R, Sonnex E, Thompson R, Mei J, Bastiany A, Welsh R. Remote ischaemic conditioning in ST elevation myocardial infarction: a registry-based randomised trial. Heart. 2022 May;108(9):703-709. doi: 10.1136/heartjnl-2021-319455. Epub 2021 Aug 20.
Results Reference
derived
Learn more about this trial
Remote Ischemic Conditioning in STEMI to Decrease Infarct Size
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