TRUST
Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion
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Status:
Ongoing. Trial began in September 2006 and is expected to complete recruiting in 2009.
Purpose:
To determine the safety and efficacy of continuous 1-hour insonation of the occluded MCA in patients with ischemic stroke treated with iv t-PA.
Year Started:
2006
Design:
Prospective, randomized, controlled, open label, parallel assignment, multicenter pilot study.
Inclusion Criteria
Acute ischemic stroke in the MCA territory according to clinical and cranial computed tomography (CT) or cranial MR imaging (MRI) findings; undergoing iv thrombolysis with t-PA within 3 hours after stroke onset; occlusion of sphenoidal (M1) or insular (M2) segment of the MCA at CT-, MR- or catheter angiography; appropriate temporal bony window without echocontrast agents for insonation with TCCS; full functional independance prior to present stroke (mRS 0-1), use of a cane for walking due to comorbid condition is acceptable.
Exclusion Criteria
Patients who have co-morbid conditions that interfere with the evaluation of endpoints, that are known to interfere with the completion of TCCS, or that affect the likelihood of survival for the 90-day follow-up period.
Patient Involvement:
All patients will be randomized to one of two groups, with the treatment group receiving continuous 1-hour insonation of the occluded MCA with 2 MHz transcranial color duplex sonography (TCCS) in addition to the iv t-PA given within 3 hours after symptom onset to the control group.
Primary Outcome:
Efficacy endpoint: functional outcome (modified Rankin scale)
Safety endpoint: rate of symptomatic intracranial hemorrhage (ICH)
Secondary Outcome:
Asymptomatic ICH occurring during or within the first 24-48 hours after t-PA infusion; early clinical recovery by >9 National Institute of Health Stroke Scale (NIHSS) points or dramatic recovery (total NIHSS score <4) at 24-48 hours after t-PA infusion; mean mRS score at 90 days after t-PA infusion; mortality rate during the study period; and recanalization at 24-48 hours after t-PA infusion.
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Source of Information:
Correspondence with trial coordinator.
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 11/2/2009
Reviewed on: 11/02/2009.
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