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
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Ontario
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Toronto, Ontario, Canada, M5B 1W8
- Recruiting
- St. Michael's Hospital
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Contact:
- Niel Fam, RCPSC
- Phone Number: 416-864-5466
- Email: famn@smh.ca
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Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
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Contact:
- Harindra Wijeysundera, MD, PhD
- Phone Number: 416-480-4527
- Email: harindra.wijeysundera@sunnybrook.ca
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Toronto, Ontario, Canada, M5G 2C4
- Recruiting
- University Health Network, Toronto General Hospital
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Principal Investigator:
- Chris Overgaard, RCPSC
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Sub-Investigator:
- Vladimir Dzavik, FRCPC, MD
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Sub-Investigator:
- Andrew Crean, MSc, FRCR
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Sub-Investigator:
- Michael Farkouh, MD, MSc
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-
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.
|
|
|
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.
|
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
Collaborators
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.