Remote Ischemic Conditioning in STEMI to Decrease Infarct Size
RemCon-STEMI
A Multi-center Randomized Trial of Remote Ischemic Conditioning to Reduce Infarct Size in Patients With an ST-Elevation Myocardial Infarction
1 other identifier
interventional
251
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedFirst Submitted
Initial submission to the registry
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2018
CompletedFirst Posted
Study publicly available on registry
April 29, 2019
CompletedApril 29, 2019
April 1, 2019
3.8 years
April 30, 2018
April 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Composite of all cause death
all cause death, cardiogenic shock or chf through 90 days
90 days
Secondary Outcomes (4)
long term survival
up to 1 year
myocardial infarction size
within 72 hours of hospital admission
ECG infarct size
with 10 days or hospital discharge whichever occurs first
Reperfusion
within 24 hours of admission to hospital
Study Arms (2)
Standard of care
PLACEBO COMPARATORno intervention will occur in the standard of care arm
Remote Ischemic Conditioning
ACTIVE COMPARATORRemote ischemic conditioning using BP cuff on left arm
Interventions
BP cuff inflation for 5 min and deflation for 5 mins with 4 cycles
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Cardiogenic shock
- History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Canadian VIGOUR Centrecollaborator
Related Publications (1)
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.
PMID: 34417205DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Patient outcomes and markers blinded to randomization arm
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 30, 2018
First Posted
April 29, 2019
Study Start
November 8, 2013
Primary Completion
August 31, 2017
Study Completion
November 26, 2018
Last Updated
April 29, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share