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

April 25, 2019 updated by: Robert Welsh, University of Alberta

A Multi-center Randomized Trial of Remote Ischemic Conditioning to Reduce Infarct Size in Patients With an ST-Elevation Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of all cause death
Time Frame: 90 days
all cause death, cardiogenic shock or chf through 90 days
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Canadian VIGOUR Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2013

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

November 26, 2018

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1 November 15, 2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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