Chronic Remote Ischemic Conditioning to Modify Post-MI Remodeling (CRIC-RCT)

July 13, 2016 updated by: The Hospital for Sick Children

Chronic Remote Ischemic Conditioning Following Primary Percutaneous Intervention for ST-Elevated Myocardial Infarction

During a heart attack, an artery carrying blood and oxygen to the heart becomes blocked, which causes damage to the heart muscle. When possible, a clot-busting drug is given or a procedure called angioplasty is performed soon after a heart attack starts, to open up the blocked artery and restore blood flow to the heart. While this can be an effective treatment to reduce permanent damage to the heart, patients can still experience heart failure afterwards. Consequently many patients require medications to support their heart after a heart attack. Recent research has shown a new technique called Remote Ischemic conditioning or RIC, is effective at protecting the heart muscle in a heart attack. RIC is produced simply by repeated inflation and deflation of a blood pressure cuff on an arm or leg to temporarily cut off and then restore blood flow to that limb. The investigators believe this triggers the release of molecular factors that protect heart muscle. In a recent study in humans, it reduced the amount of permanent damage to the heart muscle when applied before the angioplasty procedure. The investigators recent animal studies have shown that RIC may also help the heart muscle recover after a heart attack if applied everyday during the month after a heart attack, by preventing heart failure. This is important for two reasons: first, currently the investigators can only treat heart failure with medications, and second, some people have heart attacks but are not suitable to have angioplasty and so are at greater risk of heart failure. Daily RIC may provide an easy and effective new treatment to prevent heart failure after a heart attack. This application proposes a preliminary study in humans to see if daily RIC can help heart muscle recovery after a heart attack.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Contact:
          • Niel Fam, RCPSC
          • Phone Number: 416-864-5466
          • Email: famn@smh.ca
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network, Toronto General Hospital
        • Principal Investigator:
          • Chris Overgaard, RCPSC
        • Sub-Investigator:
          • Vladimir Dzavik, FRCPC, MD
        • Sub-Investigator:
          • Andrew Crean, MSc, FRCR
        • Sub-Investigator:
          • Michael Farkouh, MD, MSc

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:

(i) Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes; (ii) Antegrade TIMI 0 or 1 prior to PCI; (iii) Age ≥18 years; (iv) Informed consent from patient or next of kin.

Exclusion Criteria:

(i) Known history of diabetes; (ii) Coronary anatomy warranting emergent coronary artery bypass graft surgery; (iii) Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation); (iv) Need for hemodialysis; (v) Malignancy, HIV, or central nervous system disorder; (vi) Cardiopulmonary resuscitation >15 min and compromised level of consciousness; (vii) Cardiogenic shock; (viii) Current participation in any research study involving investigational drugs or devices; (ix) Inability to safely undergo cMRI

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic Remote Ischemic Conditioning
Remote ischemic conditioning will be induced using an AutoRIC device (occluding arm bloodflow exactly like manual bloodpressure cuff). With the participant in a supine or seated upright position, the AutoRIC device will be placed on the right arm and will inflate to a pressure of 200mmHg for 5 minutes (ischemia). The device will then auto-deflate (reperfusion), completing one cycle of ischemia-reperfusion. A total of 4 inflation and deflation cycles will occur. This will be initiated at first medical contact just prior to the performance of primary PCI in eligible subjects (RIPerC), and then repeated daily for 28 days following MI.
Device: Auto Remote Ischemic Conditioning (AutoRIC) device
Sham Comparator: SHAM Remote Ischemic Conditioning
Sham conditioning will involve the AutoRIC device being placed on the right arm and will inflate to a pressure of 10mmHg for 5 minutes (ie. no limb ischemia will occur). The device will then auto-deflate, completing one cycle. A total of 4 inflation and deflation cycles will occur. This will be initiated at first medical contact just prior to the performance of primary PCI in eligible subjects (RIPerC), and then repeated daily for 28 days following MI.
Device: Auto Remote Ischemic Conditioning (AutoRIC) device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LVEDV from baseline
Time Frame: 28 days post-surgery
The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) at 28 days post-PCI by cardiac MRI.
28 days post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in LVESV from baseline
Time Frame: 28 days post-surgery
change from baseline in left ventricular end systolic volume (LVESV), ejection fraction (LVEF) and mass at 28 days post-PCI by cardiac MRI
28 days post-surgery

Collaborators and Investigators

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

Sponsor

The Hospital for Sick Children

Collaborators

University Health Network, Toronto
Sunnybrook Health Sciences Centre
Unity Health Toronto

Investigators

  • Principal Investigator: Andrew Redington, FRCPC, The Hospital for Sick Children
  • Principal Investigator: Christopher Overgaard, RCPSC, University Health Network, Toronto General Hospital

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

March 1, 2013

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000038045

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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