Clinical trial NCT00222040: Microbubbles and Ultrasound in Stroke Trial: MUST Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Keywords: Stroke
thrombolysis
ultrasound
microbubbles
alteplase
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification.
Secondary outcomes:
measure: Rate of symptomatic intracerebral hemorrhage, mortality, Score on the modified Rankin scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Besancon
country: France
facility: Service de Neurologie
city: Montpellier
country: France
facility: Service de Neurologie, Hôpital Gui de Chauliac
city: Paris
country: France
facility: Service de Neurologie, Hôpital Sainte Anne
city: Toulouse
country: France
facility: Service de Neurologie Vasculaire, University Hospital
city: Tours
country: France
facility: Service de Neurologie, University Hospital
Study officials:
affiliation: University Hospital, Toulouse, France
name: LARRUE Vincent, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1161/hs0202.103073.
citation: 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. doi: 10.1111/j.1538-7836.2004.00746.x.
citation: 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. doi: 10.1007/s11239-005-0940-6.