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Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT00507806
Recruitment Status : Terminated (for administrative reasons)
First Posted : July 27, 2007
Last Update Posted : July 27, 2007
Sponsor:
Information provided by:
ImaRx Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: perflutren lipid microsphere Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
Study Start Date : March 2005
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Perflutren
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Drug: perflutren lipid microsphere
    Other Name: Definity

Outcome Measures
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Primary Outcome Measures :
  1. Incidence of symptomatic intracranial hemorrhage [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Complete recanalization of the occluded artery (TIBI 4-5) [ Time Frame: End of treatment ]
  2. NIHSS score of 0-2 [ Time Frame: 24 hours ]
  3. Favorable outcome (modified Rankin Scale or NIHSS 0-1) [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507806


Sponsors and Collaborators
ImaRx Therapeutics
Investigators
Principal Investigator: Andrei Alexandrov, MD The University of Texas Health Science Center, Houston
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00507806     History of Changes
Other Study ID Numbers: MRX-815-401
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: July 27, 2007
Last Verified: July 2007

Keywords provided by ImaRx Therapeutics:
Acute Ischemic Stroke
Microbubbles
Transcranial Doppler ultrasound
TIBI
 Symptomatic Intracranial Hemorrhage
modified Rankin Scale
Recanalization
Perflutren

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia