Field Implementation of the autoRIC Device in STEMI (FIRST)

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.

Study Overview

• Status: Completed
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Device: autoRIC

• Study Type: Interventional
• Enrollment (Actual): 1622
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • Brampton Civic Hospital
    • Mississauga, Ontario, Canada, L5B 1B8
      • The Mississauga Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: autoRIC; Application of the autoRIC device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: William Osler Health System
• Collaborators: Sunnybrook Health Sciences Centre; Peel Regional Paramedic Service; Halton Region Paramedic Services; Trillium Health Centre; CellAegis US, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 4, 2016
• Primary Completion (ACTUAL): July 26, 2019
• Study Completion (ACTUAL): July 26, 2019

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (ACTUAL): August 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 16-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No