Midway Evaluation - Aliona Nacu

The candidate is affiliated to the Department of Clinical Medicine. Principle Supervisor - Lars Thomassen

Abstract

Background

  Ultrasound accelerates thrombolysis with tPA (sonothrombolysis). Ultrasound in the absence of tPA also accelerates clot break-up (sonolysis). Adding intravenous gaseous microbubbles may potentiate the effect of ultrasound in both sonothrombolysis and sonolysis. The Norwegian Sonothrombolysis in Acute Stroke Study aims in a pragmatic approach to assess the effect and safety of contrast enhanced ultrasound treatment in unselected acute ischaemic stroke patients.

Methods/Design

   Acute ischaemic stroke patients ≥18 years, with or without visible arterial occlusion on computed tomography angiography (CTA) and treatable ≤ 4½ hours after symptom onset, are included in NOR-SASS. NOR-SASS is superimposed on a separate trial randomising patients with acute ischemic stroke to either tenecteplase or alteplase (The Norwegian Tenecteplase Stroke Trial NOR-TEST).  The NOR-SASS thrombolysis-arms (NOR-SASS A and B) includes patients given intravenous thrombolysis (tenecteplase or alteplase). First step randomisation of NOR-SASS A is embedded in NOR-TEST as a 1:1 randomisation to either tenecteplase or alteplase. Second step NOR-SASS randomisation is 1:1 to either contrast enhanced sonothrombolysis (CEST) or sham CEST. Randomisation in NOR-SASS B (routine alteplase group) is 1:1 to either CEST or sham CEST. Ultrasound is given for one hour using a 2-MHz pulsed-wave diagnostic ultrasound probe. Microbubble contrast (SonoVue®) is given as a continuous infusion for ~30 minutes. Recanalisation is assessed at 60 minutes after start of CEST. Magnetic resonance imaging and angiography is performed after 24 hours of stroke onset. Primary study endpoints are 1) major neurological improvement measured with NIHSS score at 24 hours and 2) favourable functional outcome defined as mRS 0-1 at 90 days.

Discussion

 NOR-SASS is the first randomised controlled trial designed to test the superiority of contrast enhanced ultrasound treatment given ≤4½ hours after stroke onset in an unselected acute ischaemic stroke population with or without a defined arterial occlusion on CTA.If a positive effect and safety can be proven, contrast enhanced ultrasound treatment will be an option for all acute ischaemic stroke patients.

Venue: Laboratory Building (Labbygget) 5,1/5,2