Remote Ischemic Conditioning in STEMI to Decrease Infarct Size

NCT ID: NCT03930589

Last Updated: 2019-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-08

Study Completion Date

2018-11-26

Brief Summary

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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

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Conditions

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STEMI CAD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Remote ischemic condition versus standard of care
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Patient outcomes and markers blinded to randomization arm

Study Groups

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Standard of care

no intervention will occur in the standard of care arm

Group Type PLACEBO_COMPARATOR

Standard of care

Intervention Type OTHER

Standard of care

Remote Ischemic Conditioning

Remote ischemic conditioning using BP cuff on left arm

Group Type ACTIVE_COMPARATOR

Remote Ischemic conditioning

Intervention Type PROCEDURE

BP cuff inflation for 5 min and deflation for 5 mins with 4 cycles

Interventions

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Remote Ischemic conditioning

BP cuff inflation for 5 min and deflation for 5 mins with 4 cycles

Intervention Type PROCEDURE

Standard of care

Standard of care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian VIGOUR Centre

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Robert Welsh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 34417205 (View on PubMed)

Other Identifiers

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V1 November 15, 2013

Identifier Type: -

Identifier Source: org_study_id

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