- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01817114
Chronic Remote Ischemic Conditioning to Modify Post-MI Remodeling (CRIC-RCT)
Chronic Remote Ischemic Conditioning Following Primary Percutaneous Intervention for ST-Elevated Myocardial Infarction
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christopher Overgaard, RCPSC
- Phone Number: 416.340.5311
- Email: chris.overgaard@uhn.ca
Study Contact Backup
- Name: Andrew Redington, FRCPC
- Phone Number: 416-813-6135
- Email: andrew.redington@sickkids.ca
Study Locations
-
-
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
- Recruiting
- SunnyBrook Health Sciences Centre
-
Contact:
- Harindra Wijeysundera, MD, PhD
- Phone Number: 416-480-4527
- Email: harindra.wijeysundera@sunnybrook.ca
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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