Field Implementation of the autoRIC Device in STEMI

NCT03265067 | Completed

• 1 other identifier: 16-0008
• Study Type: interventional
• Target: 1,622
• Locations: 1 country
• Sites: 2

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.

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 90-day MACCE

  Major adverse cardiovascular and cerebrovascular events (MACCE) in-hospital and within 90 days of PCI.

  Within 90 days of PCI

Secondary Outcomes (5)

• 30, 60 and 180-day MACCE

  Within 30, 60 and 180 days of admission

• LOS

  Time from hospital admission to hospital discharge, up to 180 days of admission

• Cardiovascular-related death

  Time from hospital admission to hospital discharge, up to 180 days of admission

• 30, 60, and 180-day cardiovascular-related readmission

  30, 60 and 180 days after index hospitalization

• Infarct size

  Time from hospital admission to hospital discharge, up to 180 days of admission

Study Arms (2)

'Before' group

NO INTERVENTION

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.

'After' group

EXPERIMENTAL

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

Interventions

autoRIC DEVICE

Application of the autoRIC device

'After' group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (2)

Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

Location

The Mississauga Hospital

Mississauga, Ontario, L5B 1B8, Canada

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: Before and after phase study

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 29, 2017
• Study Start: July 4, 2016
• Primary Completion: July 26, 2019
• Study Completion: July 26, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)