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Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
perflutren lipid microsphere
Sponsored by
ImaRx Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren

Eligibility Criteria

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

Inclusion Criteria:

  • Measurable focal neurological deficit (National Institutes of Health Stroke Scale [NIHSS] score > 4 points)
  • tPA eligible
  • Occlusion of the middle cerebral artery

Exclusion Criteria:

  • Right to left cardiac shunt
  • Uncontrolled hypertension
  • Absent temporal windows

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Incidence of symptomatic intracranial hemorrhage

    Secondary Outcome Measures

    Complete recanalization of the occluded artery (TIBI 4-5)
    NIHSS score of 0-2
    Favorable outcome (modified Rankin Scale or NIHSS 0-1)

    Full Information

    First Posted
    July 25, 2007
    Last Updated
    July 25, 2007
    Sponsor
    ImaRx Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00507806
    Brief Title
    Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
    Official Title
    Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2007
    Overall Recruitment Status
    Terminated
    Why Stopped
    for administrative reasons
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    ImaRx Therapeutics

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischemic Stroke
    Keywords
    Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    perflutren lipid microsphere
    Other Intervention Name(s)
    Definity
    Primary Outcome Measure Information:
    Title
    Incidence of symptomatic intracranial hemorrhage
    Time Frame
    72 hours
    Secondary Outcome Measure Information:
    Title
    Complete recanalization of the occluded artery (TIBI 4-5)
    Time Frame
    End of treatment
    Title
    NIHSS score of 0-2
    Time Frame
    24 hours
    Title
    Favorable outcome (modified Rankin Scale or NIHSS 0-1)
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Measurable focal neurological deficit (National Institutes of Health Stroke Scale [NIHSS] score > 4 points) tPA eligible Occlusion of the middle cerebral artery Exclusion Criteria: Right to left cardiac shunt Uncontrolled hypertension Absent temporal windows
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrei Alexandrov, MD
    Organizational Affiliation
    The University of Texas Health Science Center, Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15548777
    Citation
    Alexandrov AV, Molina CA, Grotta JC, Garami Z, Ford SR, Alvarez-Sabin J, Montaner J, Saqqur M, Demchuk AM, Moye LA, Hill MD, Wojner AW; CLOTBUST Investigators. Ultrasound-enhanced systemic thrombolysis for acute ischemic stroke. N Engl J Med. 2004 Nov 18;351(21):2170-8. doi: 10.1056/NEJMoa041175.
    Results Reference
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    Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

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