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Behavioural Intervention

Chronic Remote Ischemic Conditioning for Heart Attack (CRIC-RCT Trial)

N/A
Waitlist Available
Led By Christopher Overgaard, RCPSC
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
(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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days post-surgery
Awards & highlights

CRIC-RCT Trial 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.

Eligible Conditions
  • Heart Attack

CRIC-RCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CRIC-RCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in LVEDV from baseline
Secondary outcome measures
change in LVESV from baseline

CRIC-RCT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Chronic Remote Ischemic ConditioningExperimental Treatment1 Intervention
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.
Group II: SHAM Remote Ischemic ConditioningPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoOTHER
1,473 Previous Clinical Trials
484,985 Total Patients Enrolled
Unity Health TorontoOTHER
539 Previous Clinical Trials
447,745 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,551,288 Total Patients Enrolled

Frequently Asked Questions

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~2 spots leftby Apr 2025