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Revascularization StrategIes for ST Elevation Myocardial Infarction Trial (ASSIST-MI)

Primary Purpose

ST Elevation Myocardial Infarction, Coronary Stenting, Primary Angioplasty

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Same sitting PCI with complete revascularization
Staged PCI with complete revsacularization >48 hours pf primary PCI
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ST elevation myocardial infarction evidenced by new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2mV) in men or ≥ 1.5mm (0.15mV) in women in leads V2-V3 and/or ≥ 1mm (0.1mV) in other contiguous chest leads or limb leads.
  • MVD as evidenced by > one significant (>70% by visual assessment or FFR < 0.80 for 50-70% stenosis) stenosis in the non-IRA >2mm in diameter.
  • Successful IRA-PCI with <30% residual angiographic stenosis and TIMI III flow
  • Written informed consent

Exclusion Criteria:

  • Age ≤ 18 years
  • Prior coronary artery bypass graft (CABG) surgery
  • Administration of thrombolytic therapy.
  • Hemodynamic instability as evidenced by SBP<90 mmHg, Killip class ≥3, and/or need for inotropes/vasopressors.
  • Known renal insufficiency (estimated GFR < 30 ml/min/1.73m2)
  • Non-IRA stenosis is a chronic total occlusion (CTO)
  • Plan by treating physician to treat non-IRA stenosis with coronary artery bypass surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Same sitting complete revascularization

    Staged non-IRA PCI

    Arm 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).

    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.

    Outcomes

    Primary Outcome Measures

    Major adverse clinical events
    Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization

    Secondary Outcome Measures

    Major bleeding
    Stroke
    Contrast nephropathy
    Major vascular complication
    EQ-5D quality of life assessment
    Incremental Cost-Effectiveness Ratio (ICER)
    Myocardial infarction
    Heart failure
    All cause mortality
    Unplanned revascularization

    Full Information

    First Posted
    August 23, 2017
    Last Updated
    August 25, 2017
    Sponsor
    Unity Health Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03263468
    Brief Title
    Revascularization StrategIes for ST Elevation Myocardial Infarction Trial
    Acronym
    ASSIST-MI
    Official Title
    Revascularization StrategIes for ST Elevation Myocardial Infarction Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2017 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Unity Health Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ST Elevation Myocardial Infarction, Coronary Stenting, Primary Angioplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3520 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Same sitting complete revascularization
    Arm Type
    Experimental
    Arm 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 Title
    Staged non-IRA PCI
    Arm Type
    Active Comparator
    Arm 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(s)
    Same sitting PCI with complete revascularization
    Intervention Description
    revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting at the time of primary PCI
    Intervention Type
    Procedure
    Intervention Name(s)
    Staged PCI with complete revsacularization >48 hours pf primary PCI
    Intervention 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
    Primary Outcome Measure Information:
    Title
    Major adverse clinical events
    Description
    Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Major bleeding
    Time Frame
    90 days
    Title
    Stroke
    Time Frame
    90 days
    Title
    Contrast nephropathy
    Time Frame
    90 days
    Title
    Major vascular complication
    Time Frame
    90 days
    Title
    EQ-5D quality of life assessment
    Time Frame
    90 days
    Title
    Incremental Cost-Effectiveness Ratio (ICER)
    Time Frame
    90 days
    Title
    Myocardial infarction
    Time Frame
    90 days
    Title
    Heart failure
    Time Frame
    90 days
    Title
    All cause mortality
    Time Frame
    90 days
    Title
    Unplanned revascularization
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ST elevation myocardial infarction evidenced by new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2mV) in men or ≥ 1.5mm (0.15mV) in women in leads V2-V3 and/or ≥ 1mm (0.1mV) in other contiguous chest leads or limb leads. MVD as evidenced by > one significant (>70% by visual assessment or FFR < 0.80 for 50-70% stenosis) stenosis in the non-IRA >2mm in diameter. Successful IRA-PCI with <30% residual angiographic stenosis and TIMI III flow Written informed consent Exclusion Criteria: Age ≤ 18 years Prior coronary artery bypass graft (CABG) surgery Administration of thrombolytic therapy. Hemodynamic instability as evidenced by SBP<90 mmHg, Killip class ≥3, and/or need for inotropes/vasopressors. Known renal insufficiency (estimated GFR < 30 ml/min/1.73m2) Non-IRA stenosis is a chronic total occlusion (CTO) Plan by treating physician to treat non-IRA stenosis with coronary artery bypass surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Val Panzov
    Phone
    416-864-6060
    Ext
    7125
    Email
    panzovv@smh.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Akshay Bagai, MD
    Organizational Affiliation
    Unity Health Toronto
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Asim Cheema, MD
    Organizational Affiliation
    Unity Health Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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