Microbubbles and Ultrasound in Stroke Trial: MUST Study

Acute Ischemic Stroke Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00222040
• Other study ID #: 0302208
• Status: Terminated
• Phase: Phase 2
• First received: September 15, 2005
• Last updated: April 29, 2010
• Start date: June 2004
• Est. completion date: June 2004

Study information

• Verified date: June 2008
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Acute ischemic stroke

• MCA proximal occlusion on CT or MR angiography

• Thrombolysis with intravenous alteplase initiated within 3 hours of stroke onset

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke

Intervention

Radiation:
• Ultrasound
2-MHz, low intensity transcranial ultrasound

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

Locations

Country	Name	City	State
France	Service de Neurologie	Besancon
France	Service de Neurologie, Hôpital Gui de Chauliac	Montpellier
France	Service de Neurologie, Hôpital Sainte Anne	Paris
France	Service de Neurologie Vasculaire, University Hospital	Toulouse
France	Service de Neurologie, University Hospital	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification.			Yes
Secondary	Rate of symptomatic intracerebral hemorrhage, mortality, Score on the modified Rankin scale		3 months	Yes

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