<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03265067</url>
  </required_header>
  <id_info>
    <org_study_id>16-0008</org_study_id>
    <nct_id>NCT03265067</nct_id>
  </id_info>
  <brief_title>Field Implementation of the autoRIC Device in STEMI</brief_title>
  <acronym>FIRST</acronym>
  <official_title>Field Implementation of the autoRIC Device in STEMI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Osler Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Trillium Health Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peel Regional Paramedic Service</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Halton Region Paramedic Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CellAegis US, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>William Osler Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a &quot;before and after&quot; observational study of a therapeutic strategy to treat patients&#xD;
      with confirmed ST-segment myocardial infarction (STEMI) with remote ischemic conditioning&#xD;
      (RIC) before undergoing primary percutaneous coronary intervention (PCI). RIC is the&#xD;
      purposeful application of brief, intermittent cycles of limb occlusion by inflation/deflation&#xD;
      of a pneumatic cuff. The autoRIC device is an automatic RIC delivery device (the autoRIC®&#xD;
      Device; CellAegis Devices Inc, Toronto, ON) that has received clearance from Health Canada&#xD;
      for this use under the direction of a health care professional. Paramedics in the Peel and&#xD;
      Halton regional emergency services and the Emergency department (ED) staff of Brampton Civic&#xD;
      Hospital and Mississauga Hospital will treat patients experiencing STEMI with autoRIC, and&#xD;
      study data will be collected from existing patient records.&#xD;
&#xD;
      The 'before' group will include up to 900 patients who were treated before autoRIC&#xD;
      implementation in the services and hospitals. These patients would have had a STEMI and&#xD;
      undergone PCI, but did not receive the autoRIC device. The 'after' group will include up to&#xD;
      900 eligible patients who have had RIC treatment with the autoRIC device at the two&#xD;
      participating sites following implementation in the services and hospitals.&#xD;
&#xD;
      The primary analyses will compare the short-term and long-term outcomes of eligible patients&#xD;
      who have received completed primary PCI for STEMI in the time period before the&#xD;
      implementation and following the implementation of this RIC strategy. In addition, a health&#xD;
      economic analysis will be conducted to determine the cost-effectiveness of the therapeutic&#xD;
      strategy to treat STEMI patients with RIC prior to PCI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2016</start_date>
  <completion_date type="Actual">July 26, 2019</completion_date>
  <primary_completion_date type="Actual">July 26, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Before and after phase study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>90-day MACCE</measure>
    <time_frame>Within 90 days of PCI</time_frame>
    <description>Major adverse cardiovascular and cerebrovascular events (MACCE) in-hospital and within 90 days of PCI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30, 60 and 180-day MACCE</measure>
    <time_frame>Within 30, 60 and 180 days of admission</time_frame>
    <description>MACCE within 30, 60 and 180 days post hospital admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LOS</measure>
    <time_frame>Time from hospital admission to hospital discharge, up to 180 days of admission</time_frame>
    <description>Index hospitalization length of stay (LOS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular-related death</measure>
    <time_frame>Time from hospital admission to hospital discharge, up to 180 days of admission</time_frame>
    <description>Death due to cardiovascular related events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30, 60, and 180-day cardiovascular-related readmission</measure>
    <time_frame>30, 60 and 180 days after index hospitalization</time_frame>
    <description>Hospital readmission within 30, 60, and 180 days of index hospitalization, due to cardiovascular events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infarct size</measure>
    <time_frame>Time from hospital admission to hospital discharge, up to 180 days of admission</time_frame>
    <description>Size of infarct as measured by peak troponin level during index event admission</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1622</enrollment>
  <condition>ST Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>'Before' group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>'After' group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who underwent primary PCI for STEMI after implementation of the RIC protocol. These patients were treated with the autoRIC device prior to PCI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>autoRIC</intervention_name>
    <description>Application of the autoRIC device</description>
    <arm_group_label>'After' group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and older;&#xD;
&#xD;
          -  patients diagnosed with STEMI in the prehospital environment by responding paramedics&#xD;
             from Peel Regional Paramedic Services or Halton Emergency Medical Service and&#xD;
             transported to the PCI laboratory of Brampton Civic Hospital or Trillium Health&#xD;
             Partners;&#xD;
&#xD;
          -  walk-in patients diagnosed with STEMI in the ED of either of these two facilities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  left-bundle branch block;&#xD;
&#xD;
          -  Lymphedema on either arm&#xD;
&#xD;
          -  PICC Line on either arm&#xD;
&#xD;
          -  AV fistula or no palpable pulse on either arm;&#xD;
&#xD;
          -  patient has a known bleeding disorder or known abnormality of blood flow to the left&#xD;
             arm;&#xD;
&#xD;
          -  patient has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or&#xD;
             pre- existing traumatic injury to the limb to be treated (left-arm).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Brampton Civic Hospital</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6R 3J7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mississauga Hospital</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5B 1B8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>October 1, 2019</last_update_submitted>
  <last_update_submitted_qc>October 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Sheldon Cheskes</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265067
org study id: 16-0008
nct id: NCT03265067
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Before and after phase study
primary purpose: Other
masking: None (Open Label)
measure: 90-day MACCE
time frame: Within 90 days of PCI
description: Major adverse cardiovascular and cerebrovascular events (MACCE) in-hospital and within 90 days of PCI.
measure: 30, 60 and 180-day MACCE
time frame: Within 30, 60 and 180 days of admission
description: MACCE within 30, 60 and 180 days post hospital admission
measure: LOS
time frame: Time from hospital admission to hospital discharge, up to 180 days of admission
description: Index hospitalization length of stay (LOS)
measure: Cardiovascular-related death
time frame: Time from hospital admission to hospital discharge, up to 180 days of admission
description: Death due to cardiovascular related events
measure: 30, 60, and 180-day cardiovascular-related readmission
time frame: 30, 60 and 180 days after index hospitalization
description: Hospital readmission within 30, 60, and 180 days of index hospitalization, due to cardiovascular events.
measure: Infarct size
time frame: Time from hospital admission to hospital discharge, up to 180 days of admission
description: Size of infarct as measured by peak troponin level during index event admission
arm group label: 'Before' group
arm group type: No Intervention
description: 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.
arm group label: 'After' group
arm group type: Experimental
description: Patients who underwent primary PCI for STEMI after implementation of the RIC protocol. These patients were treated with the autoRIC device prior to PCI.
intervention type: Device
intervention name: autoRIC
description: Application of the autoRIC device
arm group label: 'After' group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Sheldon Cheskes
investigator title: Medical Director
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: No