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Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

This study has been terminated.
(for administrative reasons)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507806
First Posted: July 27, 2007
Last Update Posted: July 27, 2007
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.
Information provided by:
ImaRx Therapeutics
  Purpose
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 Intervention Phase
Acute Ischemic Stroke Drug: perflutren lipid microsphere Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by ImaRx Therapeutics:

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

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

Study Start Date: March 2005
Study Completion Date: May 2006
Intervention Details:
    Drug: perflutren lipid microsphere
    Other Name: Definity
  Eligibility

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.


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
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

Publications:
ClinicalTrials.gov Identifier: NCT00507806     History of Changes
Other Study ID Numbers: MRX-815-401
First Submitted: July 25, 2007
First Posted: July 27, 2007
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