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Field Implementation of the autoRIC Device in STEMI

NCT03265067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1622

Last updated 2019-10-02

No results posted yet for this study

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

Interventions

DEVICE

autoRIC

Application of the autoRIC device

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Trillium Health Centre

    collaborator OTHER

  • Peel Regional Paramedic Service

    collaborator UNKNOWN

  • Halton Region Paramedic Services

    collaborator OTHER

  • CellAegis US, Inc.

    collaborator INDUSTRY

  • William Osler Health System

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-04
Primary Completion
2019-07-26
Completion
2019-07-26

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03265067 on ClinicalTrials.gov