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Field Implementation of the autoRIC Device in STEMI (FIRST)

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ClinicalTrials.gov Identifier: NCT03265067
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Trillium Health Centre
Peel Regional Paramedic Service
Halton Region Paramedic Services
CellAegis US, Inc.
Information provided by (Responsible Party):
Dr. Sheldon Cheskes, Sunnybrook Health Sciences Centre

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.


Condition or disease Intervention/treatment
ST Elevation Myocardial Infarction Device: autoRIC

Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Field Implementation of the autoRIC Device in STEMI
Actual Study Start Date : July 4, 2016
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2018

Group/Cohort Intervention/treatment
'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.
'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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be conducted in the regions of Peel and Halton in the province of Ontario. These two regions have a combined population of 1.6 million. The study population comprises adult patients meeting the study criteria who are diagnosed with STEMI out of hospital or in the ED and are accepted for primary PCI reperfusion therapy at Brampton Civic Hospital (Brampton, Ontario) or Trillium Health Partners (Mississauga, Ontario) during the study period.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265067


Contacts
Contact: Sheldon Cheskes, MD 416-667-2200 ext 0 sheldon.cheskes@sunnybrook.ca
Contact: Ronald Heslegrave, PhD 9054942120 ext 29124 ronald.heslegrave@williamoslerhs.ca

Locations
Canada, Ontario
Brampton Civic Hospital Recruiting
Brampton, Ontario, Canada, L6R 3J7
Contact: Sheldon Cheskes    416-667-2200 ext 0    sheldon.cheskes@sunnybrook.ca   
The Mississauga Hospital Recruiting
Mississauga, Ontario, Canada, L5B 1B8
Contact: Sheldon Cheskes, MD    416-667-2200 ext 0    sheldon.cheskes@sunnybrook.ca   
Sponsors and Collaborators
William Osler Health System
Sunnybrook Health Sciences Centre
Trillium Health Centre
Peel Regional Paramedic Service
Halton Region Paramedic Services
CellAegis US, Inc.

Responsible Party: Dr. Sheldon Cheskes, Medical Director, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03265067     History of Changes
Other Study ID Numbers: 16-0008
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases