Suspended

CRIC-RCTChronic Remote Ischemic Conditioning Following Primary Percutaneous Intervention for ST-Elevated Myocardial Infarction

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What is being tested

Auto Remote Ischemic Conditioning (AutoRIC) device

+ Auto Remote Ischemic Conditioning (AutoRIC) device

Device
Who is being recruted

Cardiovascular Diseases+8

+ Heart Diseases

+ Infarction

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorThe Hospital for Sick Children
Study ContactChristopher Overgaard, RCPSCMore contacts
Last updated: July 15, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorThe Hospital for Sick Children
Study ContactChristopher Overgaard, RCPSCMore contacts
Last updated: July 15, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesInfarctionIschemiaNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaST Elevation Myocardial InfarctionMyocardial Infarction

Criteria

1 inclusion criteria required to participate
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

1 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

Sunnybrook Health Sciences Centre

Toronto, CanadaOpen Sunnybrook Health Sciences Centre in Google Maps
Recruiting

St. Michael's Hospital

Toronto, Canada
Recruiting

University Health Network, Toronto General Hospital

Toronto, Canada
Suspended3 Study Centers