Sonothrombolysis Potentiated by Microbubbles for Acute Ischemic Stroke
It has proposed the use of ST without microbubble treatment in randomized association with both intravenous and intra-arterial thrombolysis, but combined treatment (rtPA + U.S.) associated with MB diagnostic not yet been investigated in a randomized study.
The aim of this study is to evaluate efficacy of the combined treatment (r-rtPA+US+MB) vs the standard rtPA treatment in a randomized study in consecutive patients with acute ischemic stroke.
We expect to demonstrate that the combined treatment (rtPA+US+MB) will be statistically superior to standard treatment in terms of recanalization rate.
Other: Sulfur hexafluoride + ultrasounds
Drug: Recombinant tissue plasminogen activator
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Sonothrombolysis Potentiated by Microbubbles as a Novel Treatment of Acute Ischemic Stroke: a Prospective Randomized Pilot Study|
- Recanalization rate [ Time Frame: 6 h, 24h, and day 90 post treatmente ] [ Designated as safety issue: No ]The short term efficacy of treatment will be evaluated by recanalization rate at 6 hours control TCD (TIBI score) and at 24 hours by the NIHSS (a > 4 points improvement). As explained, the Rankin scale score will be used to test the efficacy of the treatment at day 90 after stroke onset.
|Study Start Date:||August 2012|
|Study Completion Date:||July 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Sonothrombolysis + microbubbles
rtPA+ sonovue. SonoVue sulphur hexafluoride microbubbles 8 microlitres/ml Powder and solvent for dispersion for injection 1 vial containing 25 mg lyophilized powder to be reconstituted with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection
1 pre‐filled syringe containing sodium chloride 9 mg/ml (0.9%) solution for injection
1 Mini‐Spike Plus 6/8 (CE 0123) transfer system.
1 ml of the reconstituted dispersion contains 8 microlitres sulphur hexafluoride microbubbles.
|Other: Sulfur hexafluoride + ultrasounds Drug: Recombinant tissue plasminogen activator|
Active Comparator: Standard intravenous thrombolysis
Patients in thecontrol group will use thehelmetbut without U.S continuous U.S wave emission. Serial monitoring of the status ofrecanalizationaccording to theschedule set will be carried out according to theestablished schedule
|Drug: Recombinant tissue plasminogen activator|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678495
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|