<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/NCT03263468</url>
  </required_header>
  <id_info>
    <org_study_id>17-254</org_study_id>
    <nct_id>NCT03263468</nct_id>
  </id_info>
  <brief_title>Revascularization StrategIes for ST Elevation Myocardial Infarction Trial</brief_title>
  <acronym>ASSIST-MI</acronym>
  <official_title>Revascularization StrategIes for ST Elevation Myocardial Infarction Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>Yes</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 study is being conducted in patients with a major heart attack caused by a blocked&#xD;
      artery undergoing Percutaneous Coronary Intervention (PCI) to open up the blockage. Up to 50%&#xD;
      of people with an heart attack are found to have one or more additional narrowings that did&#xD;
      not cause the heart attack. At present the best way to manage these additional blockages is&#xD;
      not known. Many cardiologist recommend opening these blockages at at a later time after the&#xD;
      heart attack. The present study is examining if PCI of all blockages at the same time as the&#xD;
      PCI for the artery that caused the major heart attack (SS-PCI) will reduce the amount of&#xD;
      heart damage compared to performing PCI of additional blockages 2-45 days later (IRA-PCI).&#xD;
      Clinical follow up will be completed at 3, 12 and 24 months to determine heart function and&#xD;
      monitor adverse events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Major adverse clinical events</measure>
    <time_frame>90 days</time_frame>
    <description>Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast nephropathy</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major vascular complication</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D quality of life assessment</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental Cost-Effectiveness Ratio (ICER)</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart failure</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned revascularization</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3520</enrollment>
  <condition>ST Elevation Myocardial Infarction</condition>
  <condition>Coronary Stenting</condition>
  <condition>Primary Angioplasty</condition>
  <arm_group>
    <arm_group_label>Same sitting complete revascularization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After treatment of the IRA, subjects will undergo PCI of all suitable significant non-IRA lesions (≥70% by visual assessment or FFR&lt;0.80 in 50-70% lesions with vessel diameter &gt;2mm).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Staged non-IRA PCI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Only the IRA will be intervened upon during the index primary PCI procedure. Staging of the non-IRA lesions will be performed 48 hours to 45 days after the primary PCI procedure. All suitable non-IRA lesions (≥70% by visual assessment or FFR&lt;0.80 in 50-70% lesions with vessel diameter &gt;2mm) will be treated with PCI irrespective of whether there are clinical symptoms or evidence of ischemia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Same sitting PCI with complete revascularization</intervention_name>
    <description>revascualrization of the non IRA (infarct related artery) of &gt; 2.0 mm by coronary angioplasty/stenting at the time of primary PCI</description>
    <arm_group_label>Same sitting complete revascularization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Staged PCI with complete revsacularization &gt;48 hours pf primary PCI</intervention_name>
    <description>revascualrization of the non IRA (infarct related artery) of &gt; 2.0 mm by coronary angioplasty/stenting &gt;48 hours to 45 days post primary PCI</description>
    <arm_group_label>Staged non-IRA PCI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ST elevation myocardial infarction evidenced by new ST elevation at the J point in at&#xD;
             least 2 contiguous leads of ≥ 2 mm (0.2mV) in men or ≥ 1.5mm (0.15mV) in women in&#xD;
             leads V2-V3 and/or ≥ 1mm (0.1mV) in other contiguous chest leads or limb leads.&#xD;
&#xD;
          -  MVD as evidenced by &gt; one significant (&gt;70% by visual assessment or FFR &lt; 0.80 for&#xD;
             50-70% stenosis) stenosis in the non-IRA &gt;2mm in diameter.&#xD;
&#xD;
          -  Successful IRA-PCI with &lt;30% residual angiographic stenosis and TIMI III flow&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age ≤ 18 years&#xD;
&#xD;
          -  Prior coronary artery bypass graft (CABG) surgery&#xD;
&#xD;
          -  Administration of thrombolytic therapy.&#xD;
&#xD;
          -  Hemodynamic instability as evidenced by SBP&lt;90 mmHg, Killip class ≥3, and/or need for&#xD;
             inotropes/vasopressors.&#xD;
&#xD;
          -  Known renal insufficiency (estimated GFR &lt; 30 ml/min/1.73m2)&#xD;
&#xD;
          -  Non-IRA stenosis is a chronic total occlusion (CTO)&#xD;
&#xD;
          -  Plan by treating physician to treat non-IRA stenosis with coronary artery bypass&#xD;
             surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Akshay Bagai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Asim Cheema, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Val Panzov</last_name>
    <phone>416-864-6060</phone>
    <phone_ext>7125</phone_ext>
    <email>panzovv@smh.ca</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Undecided</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/NCT03263468
org study id: 17-254
nct id: NCT03263468
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is being conducted in patients with a major heart attack caused by a blocked
      artery undergoing Percutaneous Coronary Intervention (PCI) to open up the blockage. Up to 50%
      of people with an heart attack are found to have one or more additional narrowings that did
      not cause the heart attack. At present the best way to manage these additional blockages is
      not known. Many cardiologist recommend opening these blockages at at a later time after the
      heart attack. The present study is examining if PCI of all blockages at the same time as the
      PCI for the artery that caused the major heart attack (SS-PCI) will reduce the amount of
      heart damage compared to performing PCI of additional blockages 2-45 days later (IRA-PCI).
      Clinical follow up will be completed at 3, 12 and 24 months to determine heart function and
      monitor adverse events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Major adverse clinical events
time frame: 90 days
description: Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization
measure: Major bleeding
time frame: 90 days
measure: Stroke
time frame: 90 days
measure: Contrast nephropathy
time frame: 90 days
measure: Major vascular complication
time frame: 90 days
measure: EQ-5D quality of life assessment
time frame: 90 days
measure: Incremental Cost-Effectiveness Ratio (ICER)
time frame: 90 days
measure: Myocardial infarction
time frame: 90 days
measure: Heart failure
time frame: 90 days
measure: All cause mortality
time frame: 90 days
measure: Unplanned revascularization
time frame: 90 days
arm group label: Same sitting complete revascularization
arm group type: Experimental
description: After treatment of the IRA, subjects will undergo PCI of all suitable significant non-IRA lesions (≥70% by visual assessment or FFR<0.80 in 50-70% lesions with vessel diameter >2mm).
arm group label: Staged non-IRA PCI
arm group type: Active Comparator
description: Only the IRA will be intervened upon during the index primary PCI procedure. Staging of the non-IRA lesions will be performed 48 hours to 45 days after the primary PCI procedure. All suitable non-IRA lesions (≥70% by visual assessment or FFR<0.80 in 50-70% lesions with vessel diameter >2mm) will be treated with PCI irrespective of whether there are clinical symptoms or evidence of ischemia.
intervention type: Procedure
intervention name: Same sitting PCI with complete revascularization
description: revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting at the time of primary PCI
arm group label: Same sitting complete revascularization
intervention type: Procedure
intervention name: Staged PCI with complete revsacularization >48 hours pf primary PCI
description: revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting >48 hours to 45 days post primary PCI
arm group label: Staged non-IRA PCI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Akshay Bagai, MD
role: Principal Investigator
affiliation: Unity Health Toronto
last name: Asim Cheema, MD
role: Principal Investigator
affiliation: Unity Health Toronto
last name: Val Panzov
phone: 416-864-6060
phone ext: 7125
email: panzovv@smh.ca
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: Undecided