Microbubbles and Ultrasound in Stroke Trial: MUST Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 20
- Locations
- 5
- Primary Endpoint
- Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Exclusion Criteria
- Not provided
Arms & Interventions
1
Levovist
Intervention: Ultrasound (Radiation)
1
Levovist
Intervention: Levovist (Drug)
Outcomes
Primary Outcomes
Rate of early recanalization on post-treatment MR or CT angiography. Recanalization is described using the tIMI classification.
Secondary Outcomes
- Rate of symptomatic intracerebral hemorrhage, mortality, Score on the modified Rankin scale(3 months)