Working… Menu

Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507806
Recruitment Status : Terminated (for administrative reasons)
First Posted : July 27, 2007
Last Update Posted : July 27, 2007
Information provided by:
ImaRx Therapeutics

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

Layout table for study information
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

Intervention Details:
  • Drug: perflutren lipid microsphere
    Other Name: Definity

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00507806

Sponsors and Collaborators
ImaRx Therapeutics
Layout table for investigator information
Principal Investigator: Andrei Alexandrov, MD The University of Texas Health Science Center, Houston
Layout table for additonal information Identifier: NCT00507806    
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
Transcranial Doppler ultrasound
Symptomatic Intracranial Hemorrhage
modified Rankin Scale
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia