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The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tirofiban
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Angioplasty, Transluminal, Percutaneous Coronary, tirofiban, Magnetic Resonance Imaging, Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
  • ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage

Exclusion Criteria:

  • hemodynamic instability
  • history of MI
  • old age > 80years
  • Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    1

    2

    Arm Description

    Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose

    Aspirin, clopidogrel, unfractionated heparin

    Outcomes

    Primary Outcome Measures

    Infarct size and its transmural extent using MRI

    Secondary Outcome Measures

    pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography

    Full Information

    First Posted
    January 27, 2008
    Last Updated
    February 7, 2008
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00611169
    Brief Title
    The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction
    Official Title
    The Effects of Facilitated Percutaeous Coronary Intervention Compared to Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Acute Myocardial Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myocardial Infarction
    Keywords
    Angioplasty, Transluminal, Percutaneous Coronary, tirofiban, Magnetic Resonance Imaging, Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose
    Arm Title
    2
    Arm Type
    No Intervention
    Arm Description
    Aspirin, clopidogrel, unfractionated heparin
    Intervention Type
    Drug
    Intervention Name(s)
    tirofiban
    Intervention Description
    tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)
    Primary Outcome Measure Information:
    Title
    Infarct size and its transmural extent using MRI
    Time Frame
    within the first 30 days after index procedure
    Secondary Outcome Measure Information:
    Title
    pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography
    Time Frame
    at 6 month after index procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage Exclusion Criteria: hemodynamic instability history of MI old age > 80years Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hyeon-Cheol Gwon, MD, PhD
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction

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