Field Implementation of the autoRIC Device in STEMI (FIRST)
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|ClinicalTrials.gov Identifier: NCT03265067|
Recruitment Status : Active, not recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|ST Elevation Myocardial Infarction||Device: autoRIC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1800 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Before and after phase study|
|Masking:||None (Open Label)|
|Official Title:||Field Implementation of the autoRIC Device in STEMI|
|Actual Study Start Date :||July 4, 2016|
|Estimated Primary Completion Date :||November 30, 2018|
|Estimated Study Completion Date :||March 31, 2019|
No Intervention: 'Before' group
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
Patients who underwent primary PCI for STEMI after implementation of the RIC protocol. These patients were treated with the autoRIC device prior to PCI.
Application of the autoRIC device
- 90-day MACCE [ Time Frame: Within 90 days of PCI ]Major adverse cardiovascular and cerebrovascular events (MACCE) in-hospital and within 90 days of PCI.
- 30, 60 and 180-day MACCE [ Time Frame: Within 30, 60 and 180 days of admission ]MACCE within 30, 60 and 180 days post hospital admission
- LOS [ Time Frame: Time from hospital admission to hospital discharge, up to 180 days of admission ]Index hospitalization length of stay (LOS)
- Cardiovascular-related death [ Time Frame: Time from hospital admission to hospital discharge, up to 180 days of admission ]Death due to cardiovascular related events
- 30, 60, and 180-day cardiovascular-related readmission [ 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.
- Infarct size [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265067
|Brampton Civic Hospital|
|Brampton, Ontario, Canada, L6R 3J7|
|The Mississauga Hospital|
|Mississauga, Ontario, Canada, L5B 1B8|