Microbubbles and Ultrasound in Stroke Trial: MUST Study
Information source: University Hospital, Toulouse
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Ischemic Stroke
Intervention: US : 2-MHz, low intensity transcranial ultrasound (Device); Levovist (D-Galactose palmityl coated microbubbles) (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: University Hospital, Toulouse Official(s) and/or principal investigator(s):
LARRUE Vincent, MD, Principal Investigator, Affiliation: University Hospital Toulouse, FRANCE
Summary
To determine whether transcranial 2-MHz ultrasound combined with intravenous admninistration
of microbubbles improves early recanalization in patients with acute ischemic stroke caused
by middle cerebral artery (MCA) proximal occlusion treted with intravenous alteplase within
3 hours of symptom onset.
Clinical Details
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification.
Secondary outcome: Rate of symptomatic intracerebral hemorrhage, mortality, Score on the modified Rankin scale at 3 months.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Acute ischemic stroke, MCA proximal occlusion on CT or MR angiography, thrombolysis with
intravenous alteplase is indicated and can be initiated within 3 hours of stroke onset,the
study treatment (ultrasound combined with microbubbles) can be initiated within 3 hours of
symptom onset.
Locations and Contacts
Service de Neurologie Vasculaire, University Hospital, TOULOUSE 31059, France
Service de Neurologie, BESANCON 25030, France
Service de Neurologie, University Hospital, Tours 37044, France
Service de Neurologie, Hôpital Gui de Chauliac, MONTPELLIER 34295, France
Service de Neurologie, Hôpital Sainte Anne, PARIS 75674, France
Additional Information
Related publications: Cintas P, Le Traon AP, Larrue V. High rate of recanalization of middle cerebral artery occlusion during 2-MHz transcranial color-coded Doppler continuous monitoring without thrombolytic drug. Stroke. 2002 Feb;33(2):626-8. Cintas P, Nguyen F, Boneu B, Larrue V. Enhancement of enzymatic fibrinolysis with 2-MHz ultrasound and microbubbles. J Thromb Haemost. 2004 Jul;2(7):1163-6. Viguier A, Petit R, Rigal M, Cintas P, Larrue V. Continuous monitoring of middle cerebral artery recanalization with transcranial color-coded sonography and Levovist. J Thromb Thrombolysis. 2005 Feb;19(1):55-9.
Starting date: June 2004
Ending date: June 2004
Last updated: January 30, 2007
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