Acute Ischemic Stroke Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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