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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Hospital for Sick Children
Sponsor:
Collaborators:
University Health Network, Toronto
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Andrew Redington, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01817114
First received: March 20, 2013
Last updated: December 2, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 82
Study Start Date: March 2013
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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         
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   
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

No publications provided

Responsible Party: Andrew Redington, Dr. Andrew Redington, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01817114     History of Changes
Other Study ID Numbers: 1000023324
Study First Received: March 20, 2013
Last Updated: December 2, 2013
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 28, 2014