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Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

This study has been terminated.
(for administrative reasons)
Sponsor:
Information provided by:
ImaRx Therapeutics
ClinicalTrials.gov Identifier:
NCT00507806
First received: July 25, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Resource links provided by NLM:

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 25, 2007
Last Updated: July 25, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013