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

This study is currently recruiting participants.
Verified July 2016 by The Hospital for Sick Children
Sponsor:
ClinicalTrials.gov Identifier:
NCT01817114
First Posted: March 22, 2013
Last Update Posted: July 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University Health Network, Toronto
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
The Hospital for Sick Children
  Purpose
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.

Condition Intervention
Myocardial Infarction Device: Auto Remote Ischemic Conditioning (AutoRIC) device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Chronic Remote Ischemic Conditioning Following Primary Percutaneous Intervention for ST-Elevated Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817114


Contacts
Contact: Christopher Overgaard, RCPSC 416.340.5311 chris.overgaard@uhn.ca
Contact: Andrew Redington, FRCPC 416-813-6135 andrew.redington@sickkids.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Harindra Wijeysundera, MD, PhD    416-480-4527    harindra.wijeysundera@sunnybrook.ca   
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Niel Fam, RCPSC    416-864-5466    famn@smh.ca   
University Health Network, Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Principal Investigator: Chris Overgaard, RCPSC         
Sub-Investigator: Vladimir Dzavik, FRCPC, MD         
Sub-Investigator: Andrew Crean, MSc, FRCR         
Sub-Investigator: Michael Farkouh, MD, MSc         
Sponsors and Collaborators
The Hospital for Sick Children
University Health Network, Toronto
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Andrew Redington, FRCPC The Hospital for Sick Children
Principal Investigator: Christopher Overgaard, RCPSC University Health Network, Toronto General Hospital
  More Information

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01817114     History of Changes
Other Study ID Numbers: 1000038045
First Submitted: March 20, 2013
First Posted: March 22, 2013
Last Update Posted: July 15, 2016
Last Verified: July 2016

Keywords provided by The Hospital for Sick Children:
Remote Ischemic Conditioning
PCI
STEMI
LAD

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases