Clinical trial NCT03265067: Field Implementation of the autoRIC Device in STEMI
Official title: Field Implementation of the autoRIC Device in STEMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Lead sponsor: William Osler Health System
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Trillium Health Centre
name: Peel Regional Paramedic Service
name: Halton Region Paramedic Services
name: CellAegis US, Inc.
First posted: 2017-08-29
Enrollment: 1622
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Before and after phase study
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: 90-day MACCE
timeFrame: Within 90 days of PCI
Secondary outcomes:
measure: 30, 60 and 180-day MACCE
timeFrame: Within 30, 60 and 180 days of admission
measure: LOS
timeFrame: Time from hospital admission to hospital discharge, up to 180 days of admission
measure: Cardiovascular-related death
timeFrame: Time from hospital admission to hospital discharge, up to 180 days of admission
measure: 30, 60, and 180-day cardiovascular-related readmission
timeFrame: 30, 60 and 180 days after index hospitalization
measure: Infarct size
timeFrame: Time from hospital admission to hospital discharge, up to 180 days of admission
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Brampton Civic Hospital
state: Ontario
city: Mississauga
country: Canada
facility: The Mississauga Hospital
state: Ontario
Study officials:
References: