Field Implementation of the autoRIC Device in STEMI

Study Overview
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Brief Summary
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This is a before and after observational study of a therapeutic strategy to treat patients with confirmed ST-segment myocardial infarction (STEMI) with remote ischemic conditioning (RIC) before undergoing primary percutaneous coronary intervention (PCI). RIC is the purposeful application of brief, intermittent cycles of limb occlusion by inflation/deflation of a pneumatic cuff. The autoRIC device is an automatic RIC delivery device (the autoRIC® Device; CellAegis Devices Inc, Toronto, ON) that has received clearance from Health Canada for this use under the direction of a health care professional. Paramedics in the Peel and Halton regional emergency services and the Emergency department (ED) staff of Brampton Civic Hospital and Mississauga Hospital will treat patients experiencing STEMI with autoRIC, and study data will be collected from existing patient records. The 'before' group will include up to 900 patients who were treated before autoRIC implementation in the services and hospitals. These patients would have had a STEMI and undergone PCI, but did not receive the autoRIC device. The 'after' group will include up to 900 eligible patients who have had RIC treatment with the autoRIC device at the two participating sites following implementation in the services and hospitals. The primary analyses will compare the short-term and long-term outcomes of eligible patients who have received completed primary PCI for STEMI in the time period before the implementation and following the implementation of this RIC strategy. In addition, a health economic analysis will be conducted to determine the cost-effectiveness of the therapeutic strategy to treat STEMI patients with RIC prior to PCI.

Official Title
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Field Implementation of the autoRIC Device in STEMI

Conditions
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ST Elevation Myocardial Infarction

Intervention / Treatment
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* Device: autoRIC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older; patients diagnosed with STEMI in the prehospital environment by responding paramedics from Peel Regional Paramedic Services or Halton Emergency Medical Service and transported to the PCI laboratory of Brampton Civic Hospital or Trillium Health Partners; walk-in patients diagnosed with STEMI in the ED of either of these two facilities. Exclusion Criteria: left-bundle branch block; Lymphedema on either arm PICC Line on either arm AV fistula or no palpable pulse on either arm; patient has a known bleeding disorder or known abnormality of blood flow to the left arm; patient has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre- existing traumatic injury to the limb to be treated (left-arm).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Before and after phase study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 'Before' group<br>Patients who underwent primary PCI for STEMI prior to implementation of the RIC protol. These patients were not treated with the autoRIC device prior to PCI. | |
| Experimental: 'After' group<br>Patients who underwent primary PCI for STEMI after implementation of the RIC protocol. These patients were treated with the autoRIC device prior to PCI. | Device: autoRIC<br>* Application of the autoRIC device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day MACCE | Major adverse cardiovascular and cerebrovascular events (MACCE) in-hospital and within 90 days of PCI. | Within 90 days of PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30, 60 and 180-day MACCE | MACCE within 30, 60 and 180 days post hospital admission | Within 30, 60 and 180 days of admission | 
| LOS | Index hospitalization length of stay (LOS) | Time from hospital admission to hospital discharge, up to 180 days of admission | 
| Cardiovascular-related death | Death due to cardiovascular related events | Time from hospital admission to hospital discharge, up to 180 days of admission | 
| 30, 60, and 180-day cardiovascular-related readmission | Hospital readmission within 30, 60, and 180 days of index hospitalization, due to cardiovascular events. | 30, 60 and 180 days after index hospitalization | 
| Infarct size | Size of infarct as measured by peak troponin level during index event admission | Time from hospital admission to hospital discharge, up to 180 days of admission |