Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222040
Status:
TERMINATED
Last Update Posted:
2010-04-30
First Post:
2005-09-15
Brief Title:
Microbubbles and Ultrasound in Stroke Trial MUST Study
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2008-06
Last Known Status:
None
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:
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 thrombusblood 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
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 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