Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336596
Status:
UNKNOWN
Last Update Posted:
2007-04-27
First Post:
2006-06-13
Brief Title:
Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Transcranial Ultrasound Enhanced Thrombolysis TRUST
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the present randomized controlled multicenter phase III trial is to investigate the safety and efficacy of continuous 1-hour insonation of occluded middle cerebral artery with 2 MHz TCCS in stroke patients treated with intravenous tissue plasminogen activator t-PA within 3 hours after symptom onset
Detailed Description:
Thrombolysis with intravenousiv tissue plasminogen activator t-PA is the only effective and approved therapy for acute ischemic stroke The most frequent cause of ischemic stroke is thrombosis of the middle cerebral artery MCA Preliminary in vitro animal and human studies suggest that ultrasound accelerates thrombolysis induced by t-PA and recanalization of acute MCA occlusion due to thrombolysis is an independent predictor of good clinical outcome Thus insonation of an occluded MCA through the temporal bone in stroke patients who are treated with iv t-PA might enhance recanalization and improve clinical outcome The present prospective randomized controlled multicenter pilot study will investigate the safety and efficacy of continuous 1-hour insonation of the occluded MCA with 2 MHz transcranial color duplex sonography in patients with ischemic stroke treated with iv t-PA within 3 hours after symptom onset It is planned to randomize 400 patients in 6 Swiss centers during an enrolment period of 33 months with an individual follow up of 3 months The study endpoints include safety and efficacy assessments The primary safety endpoint is to determine the rate of symptomatic intracranial hemorrhage ICH in both treatment groups The primary efficacy endpoint is to determine whether a good functional outcome modified Rankin scale mRs score of 0-2 differs between both treatment groups Secondary endpoints include 1 asymptomatic ICH occuring during or within the first 24-48 hours after t-PA infusion 2 early clinical recovery by 10 or more National Institute of Health Stroke Scale NIHSS points or dramatic recovery total NIHSS score of 3 or less at 24-48 hours after t-PA infusion 3 mean mRS score at 90 days after t-PA infusion 4 death occuring during the study period and 5 recanalization at 24-48 hours after t-PA infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None