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Microbubbles and Ultrasound in Stroke Trial: MUST Study

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: NCT00222040
Recruitment Status : Terminated
First Posted : September 22, 2005
Last Update Posted : April 30, 2010
Ministry of Health, France
Information provided by:
University Hospital, Toulouse

Brief Summary:
To determine whether transcranial 2-MHz ultrasound combined with intravenous administration of microbubbles improves early recanalization in patients with acute ischemic stroke caused by middle cerebral artery (MCA) proximal occlusion treated with intravenous alteplase within 3 hours of symptom onset.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Radiation: Ultrasound Drug: Levovist Phase 2

Detailed Description:

Proximal MCA occlusion is recognized using MR or CT angiography performed before inclusion. All patients are treated with alteplase according to current guidelines. In addition, patients randomized in the active group are continuously exposed to transcranial 2-MHz ultrasound for 1 hour combined with intravenous administration of microbubbles. Controls are only treated with alteplase. The ultrasound beam is positioned at the thrombus/blood flow interface using color-coded sonography. Galactose-based microbubbles are administered via continuous intravenous infusion over 40 min.

Early recanalization is assessed using MR or CT angiography 4 to 8 hours after symptom onset. The evaluation of angiograms is performed by 2 neuroradiologists blinded to group of randomization and clinical details. The primary outcome measure is the rate of early recanalization. Recanalization is assessed using the TIMI classification. Secondary endpoints include the rate of symptomatic intracerebral hemorrhage, mortality, and functional outcome on the modified Rankin scale at 3 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2004
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: 1
Radiation: Ultrasound
2-MHz, low intensity transcranial ultrasound

Drug: Levovist
D-Galactose and palmitic palmitique intravenous 4 g

No Intervention: 2
No specific intervention

Primary Outcome Measures :
  1. Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification.

Secondary Outcome Measures :
  1. Rate of symptomatic intracerebral hemorrhage, mortality, Score on the modified Rankin scale [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute ischemic stroke
  • MCA proximal occlusion on CT or MR angiography
  • Thrombolysis with intravenous alteplase initiated within 3 hours of stroke onset

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): NCT00222040

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Service de Neurologie
Besancon, France, 25030
Service de Neurologie, Hôpital Gui de Chauliac
Montpellier, France, 34295
Service de Neurologie, Hôpital Sainte Anne
Paris, France, 75674
Service de Neurologie Vasculaire, University Hospital
Toulouse, France, 31059
Service de Neurologie, University Hospital
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Toulouse
Ministry of Health, France
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Principal Investigator: LARRUE Vincent, MD University Hospital, Toulouse, France
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Responsible Party: LLAU Marie-Elise, University Hospital Toulouse Identifier: NCT00222040    
Other Study ID Numbers: 0302208
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: June 2008
Keywords provided by University Hospital, Toulouse:
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases