M. Del Sette 1, S. Ricci 2, E. Giorli 1, M. Cotroneo 3
1 Neurology Unit – La Spezia, Italy,
2 Stroke Unit – Città di Castello, Italy,
3 Department of Neurology University of Messina – Messina, Italy
Objective: sonothrombolysis (ST) can increase the penetration of circulating tPA into the thrombus, promote the breaking and cleaving of the fibrin polymers, and improve the binding affinity of tPA to fibrin. A recent Cochrane Review of all the randomized studies published on ST reported significantly more recanalizations and better clinical outcome, with no effect on mortality. The ultras study is a pilot study aiming at defining efficacy of ST in acute ischemic stroke.
Material and Methods: This is a multicenter, interventional, controlled, randomized study. Patients older than 18 years will be enrolled if presenting with acute IS within 4.5 of symptom onset. They will undergo to blood tests, ECG, brain CT, carotid US, TCCD or TCD. Patients should have an occlusion of the middle cerebral artery documented by TCD, TCCD or CTA. Exclusion criteria will be: cerebral hemorrhage on CT and dramatic spontaneous neurologic improvement. Informed consent will be obtained from all patients or their next of kin. Patients will be randomized to receive either tPA alone or tPA + US (1 hour exposure to US delivered by a 2-MHz TCD probe during tPA infusion).
Results: The primary endpoints will be clinical improvement assessed by NIHSS at 6, 12 and 24 hours from treatment. Clinical improvement will be defined as a change greater than 4 points in NIHSS at 24 hours after treatment. Secondary endpoints will be early (<6 h ) recanalization rates, clinical outcome (modified Rankin Scale) at 3 months from stroke onset, frequency of cerebral hemorrhage (symptomatic and asymptomatic), mortality (assessed at 24 h and 3 months from treatment).
Discussion: ST is a promising tool for ischemic stroke treatment. ULTRAS pilot study will provide us further data to be added to previous study and basis for more effort in this promising direction.
Key words: acute stroke, randomized trial, thrombolysis.