Microbubbles and Ultrasound in Stroke Trial: MUST Study

Phase 2

Terminated

• Conditions: Acute Ischemic Stroke
• Interventions: Radiation: Ultrasound; Drug: Levovist

• Registration Number: NCT00222040
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-22
• Status Verified: 2008-06
• Last Update Submitted: 2010-04-29
• Last Update Posted: 2010-04-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ultrasound	Levovist
1	Levovist	Levovist

Primary Outcome Measures

Name	Time	Method
Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification.

Secondary Outcome Measures

Name	Time	Method
Rate of symptomatic intracerebral hemorrhage, mortality, Score on the modified Rankin scale	3 months

Trial Locations

Locations (5)

Service de Neurologie, Hôpital Sainte Anne; 🇫🇷 Paris, France

Service de Neurologie; 🇫🇷 Besancon, France

Service de Neurologie, Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

Service de Neurologie Vasculaire, University Hospital; 🇫🇷 Toulouse, France

Service de Neurologie, University Hospital; 🇫🇷 Tours, France