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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Unknown status

CT.gov ID

NCT01817114

Collaborator

University Health Network, Toronto (Other), Sunnybrook Health Sciences Centre (Other), Unity Health Toronto (Other)

Enrollment

Locations

Arms

Duration (Months)

6.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Device: Auto Remote Ischemic Conditioning (AutoRIC) device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

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

Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in LVEDV from baseline [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
2	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
3	University Health Network, Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

The Hospital for Sick Children
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