Remote Ischemic Conditioning in STEMI to Decrease Infarct Size

Not Applicable

Completed

• Conditions: CAD; STEMI
• Interventions: Other: Standard of care; Procedure: Remote Ischemic conditioning

• Registration Number: NCT03930589
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-11-08
• Primary Completion: 2017-08-31
• Study First Submitted: 2018-04-30
• Study Completion: 2018-11-26
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-25
• Last Update Submitted: 2019-04-25
• Study First Posted: 2019-04-29
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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)

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	no intervention will occur in the standard of care arm
Remote Ischemic Conditioning	Remote Ischemic conditioning	Remote ischemic conditioning using BP cuff on left arm

Primary Outcome Measures

Name	Time	Method
Composite of all cause death	90 days	all cause death, cardiogenic shock or chf through 90 days

Secondary Outcome Measures

Name	Time	Method
long term survival	up to 1 year	survival
myocardial infarction size	within 72 hours of hospital admission	mi size using peak elevation of cardiac biomarkers
ECG infarct size	with 10 days or hospital discharge whichever occurs first	QRS score on baseline and discharge ECGS
Reperfusion	within 24 hours of admission to hospital	ST segment resolution 30 minutes post PCI