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Completed

NCT Number: NCT03265067

Field Implementation of the autoRIC Device in STEMI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brampton Civic Hospital, Brampton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

autoRIC

Device

Application of the autoRIC device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. LOS

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

    Index hospitalization length of stay (LOS)

  3. Cardiovascular-related death

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

    Death due to cardiovascular related events

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

William Osler Health System

Other

Collaborators

  • CellAegis US, Inc.
  • Halton Region Paramedic Services
  • Peel Regional Paramedic Service
  • Sunnybrook Health Sciences Centre
  • Trillium Health Centre

Registry information

Acronym: FIRST

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2017
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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