ST Elevation Myocardial Infarction Clinical Trial
Official title:
Field Implementation of the autoRIC Device in STEMI
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.
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