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Microbubbles and Ultrasound in Stroke Trial: MUST Study

This study has been terminated.
Ministry of Health, France
Information provided by:
University Hospital, Toulouse Identifier:
First received: September 15, 2005
Last updated: April 29, 2010
Last verified: June 2008
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 Intervention Phase
Acute Ischemic Stroke Radiation: Ultrasound Drug: Levovist Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University Hospital, Toulouse:

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

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

Enrollment: 20
Study Start Date: June 2004
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00222040

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
Principal Investigator: LARRUE Vincent, MD University Hospital Toulouse, FRANCE
  More Information

Additional Information:
Responsible Party: LLAU Marie-Elise, University Hospital Toulouse Identifier: NCT00222040     History of Changes
Other Study ID Numbers: 0302208
Study First Received: September 15, 2005
Last Updated: April 29, 2010

Keywords provided by University Hospital, Toulouse:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 25, 2017