autoRIC
DeviceApplication of the autoRIC device
NCT Number: NCT03265067
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Brampton Civic Hospital, Brampton, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of the autoRIC device
Time frame: Within 90 days of PCI
Major adverse cardiovascular and cerebrovascular events (MACCE) in-hospital and within 90 days of PCI.
Time frame: Within 30, 60 and 180 days of admission
MACCE within 30, 60 and 180 days post hospital admission
Time frame: Time from hospital admission to hospital discharge, up to 180 days of admission
Index hospitalization length of stay (LOS)
Time frame: Time from hospital admission to hospital discharge, up to 180 days of admission
Death due to cardiovascular related events
Time frame: 30, 60 and 180 days after index hospitalization
Hospital readmission within 30, 60, and 180 days of index hospitalization, due to cardiovascular events.
Time frame: Time from hospital admission to hospital discharge, up to 180 days of admission
Size of infarct as measured by peak troponin level during index event admission
William Osler Health System
Other
Acronym: FIRST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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