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Use of Export in Primary Percutaneous Coronary Intervention (EPISOO)

Primary Purpose

ST-segment Elevation Myocardial Infarction (STEMI), Total Occlusion of Coronary Artery, Primary Percutaneous Coronary Intervention

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Export Catheter
Balloon catheter
Sponsored by
National Institute of Cardiovascular Diseases, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction (STEMI)

Eligibility Criteria

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

Inclusion Criteria:

  • Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes
  • Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
  • Chest pain < 12 hours duration
  • Total occlusion (TIMI 0 flow)
  • Patients undergoing primary PCI
  • Informed consent

Exclusion Criteria:

  • Patients with prior history of cardiac related surgery or intervention
  • Performance of a rescue PCI after thrombolysis
  • Known existence of a disease resulting in a life expectancy of less than 6 months
  • Killip class III, IV

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Group

    Control group

    Arm Description

    Manual thrombus aspiration (use of export catheter) followed by primary PCI

    Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI

    Outcomes

    Primary Outcome Measures

    Post thrombus aspiration TIMI flow
    Immediate TIMI flow after export/balloon
    Slow/No-reflow
    TIMI 0-II flow
    Major adverse cardiac events
    It will include All-cause death, Cardiovascular death, Re- infarction, Heart Failure, Cardiogenic shock, Cerebrovascular events, Bleeding events, and Stent thrombosis

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2021
    Last Updated
    August 31, 2023
    Sponsor
    National Institute of Cardiovascular Diseases, Pakistan
    Collaborators
    Medtronic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05510661
    Brief Title
    Use of Export in Primary Percutaneous Coronary Intervention
    Acronym
    EPISOO
    Official Title
    Use of Export in Primary Percutaneous Coronary Intervention, In-Hospital and Short-term Outcomes and Optimal Time of Export
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    September 15, 2024 (Anticipated)
    Study Completion Date
    October 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Institute of Cardiovascular Diseases, Pakistan
    Collaborators
    Medtronic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Aim of this single center randomized open label trial with blinded in-hospital outcomes assessment is designed with aim to compare manual thrombus aspiration followed by percutaneous coronary intervention (PCI) strategy with PCI alone.
    Detailed Description
    Clinical benefit of manual aspiration has been a contentious point of debate and it is Class III indication in current clinical practice guidelines, however, recent observational data by Kumar D et al. showed benefits of usage of export in terms of favorable in-hospital outcomes and lesser complication rate in patients with total occlusion, furthermore, benefits of usage of export was observed to be directly associated with duration of chest pain at the time of thrombus aspiration. However, these observations are limited to immediate and in-hospital outcomes and data regarding efficacy of manual thrombus aspiration are not available. Hence this single center randomized open label trial is designed with specific aim to test the following hypothesis for STEMI patients with total occlusion undergoing primary PCI; Whether use of export catheter reduces in-hospital and short term adverse events Whether use of export reduces slow flow or no reflow Whether use of export reduces the use of intracoronary drugs Whether use of export within 6 hours of symptom onset significantly reduces in-hospital and short term adverse events Consecutively recruited patients will be randomized to either primary PCI with export or primary PCI alone group in 2:1 ratio. Post aspiration immediate TIMI flow will be observed and all the patients will be observed for adverse outcomes (MACE) and complications including slow flow/no-reflow. Follow-up intervals will be at the end of one month of randomization and end of 6 month of randomization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ST-segment Elevation Myocardial Infarction (STEMI), Total Occlusion of Coronary Artery, Primary Percutaneous Coronary Intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Manual thrombus aspiration (use of export catheter) followed by primary PCI
    Masking
    Outcomes Assessor
    Masking Description
    Blinded in-hospital outcomes assessment will be insured by separating patients recruitment and follow-up team and follow-up team will be kept blinded of randomization. All the patients will be assigned a unique identity code and collected data will be stored against the assigned code.
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Manual thrombus aspiration (use of export catheter) followed by primary PCI
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI
    Intervention Type
    Device
    Intervention Name(s)
    Export Catheter
    Other Intervention Name(s)
    Thrombus Aspiration
    Intervention Description
    Manual thrombus aspiration with the use of export catheter during primary PCI
    Intervention Type
    Device
    Intervention Name(s)
    Balloon catheter
    Intervention Description
    Predilatation with balloon catheter
    Primary Outcome Measure Information:
    Title
    Post thrombus aspiration TIMI flow
    Description
    Immediate TIMI flow after export/balloon
    Time Frame
    Immediately after export/balloon
    Title
    Slow/No-reflow
    Description
    TIMI 0-II flow
    Time Frame
    Immediately after procedure
    Title
    Major adverse cardiac events
    Description
    It will include All-cause death, Cardiovascular death, Re- infarction, Heart Failure, Cardiogenic shock, Cerebrovascular events, Bleeding events, and Stent thrombosis
    Time Frame
    In-hospital, at 1 month, and at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads Chest pain < 12 hours duration Total occlusion (TIMI 0 flow) Patients undergoing primary PCI Informed consent Exclusion Criteria: Patients with prior history of cardiac related surgery or intervention Performance of a rescue PCI after thrombolysis Known existence of a disease resulting in a life expectancy of less than 6 months Killip class III, IV
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr Faiza Farooq, FCPS
    Phone
    +923002426460
    Email
    drffaziz@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tahir Saghir, FCPS
    Phone
    +923002199844
    Email
    tahirsaghir@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr Fiaza Farooq, FCPS
    Organizational Affiliation
    National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Kumar D, Saghir T, Sial JA, Kumar R, Karim M, Huma ZE, Qamar N. Use of export vs. balloon in primary percutaneous coronary intervention, in-hospital outcomes and optimal export time. Journal of the American College of Cardiology. 2021 May 11; 77(18_Supplement_1): 1034.
    Results Reference
    result

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    Use of Export in Primary Percutaneous Coronary Intervention

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