title: Computed tomography perfusion-based thrombolysis in wake-up stroke.
abstract: Wake-up stroke (WUS) patients are typically excluded from reperfusion treatment, as the time of symptoms onset is unknown. The purpose of this study is to evaluate the clinical outcome and safety of intravenous thrombolysis with rt-PA in patients with WUS eligible for therapy using computed tomography perfusion criteria (CTP), compared to patients treated with rt-PA within 4.5 h of symptoms onset (non-WUS). This is an experimental, open-label trial, controlled against the best therapy currently in use. Primary endpoints were functional independence after 3 months [modified Rankin scale (mRS) ≤ 1] for clinical outcome and symptomatic intracerebral hemorrhage (SICH) for safety. Secondary endpoints were no or only mild disability after 3 months (mRS ≤ 2) for clinical outcome, total intracerebral hemorrhage (TICH) and contrast-induced nephropathy (CIN) for safety. 170 patients were treated, 143 non-WUS patients and 27 patients with WUS. Strokes of cardioembolic origin were most common in WUS patients (p < 0.001). Primary endpoints: mRS ≤ 1 was found in 35.8 % (non-WUS: 36.4% vs. WUS 33.3%; p = 0.62) and SICH was observed in 3.4 % of non-WUS patients and in WUS patients (p = 0.32). Secondary endpoints: mRS ≤ 2 was observed in 66.4 % of patients (non-WUS: 67.1% vs. WUS 62.9%; p = 0.67), TICH in 13.5 % of patients (13.9 % non-WUS vs. 11.1 % WUS; p = 0.69). CIN was documented in 3.7 % of WUS patients. rt-PA treatment carried out in WUS patients selected on the basis of CTP data demonstrate comparable clinical outcome and safety with respect to non-WUS patients. The study supports the hypothesis that a selected group of WUS patients may be suitable for thrombolysis.
authors.affiliation: Neurology Unit, Guglielmo da Saliceto Hospital, Via Taverna 49, 29121, Piacenza, Italy. nicola.morelli.md@gmail.com.|Radiology Unit, Guglielmo da Saliceto Hospital, Piacenza, Italy. nicola.morelli.md@gmail.com.
authors.forename: Nicola
authors.initials: N
authors.lastname: Morelli
authors.affiliation: Neurology Unit, Guglielmo da Saliceto Hospital, Via Taverna 49, 29121, Piacenza, Italy.
authors.forename: Eugenia
authors.initials: E
authors.lastname: Rota
authors.affiliation: Neurology Unit, Guglielmo da Saliceto Hospital, Via Taverna 49, 29121, Piacenza, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Immovilli
authors.affiliation: Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
authors.forename: Mirco
authors.initials: M
authors.lastname: Cosottini
authors.affiliation: Emergency Department, Hospital of Val d'Arda, Piacenza, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Giorgi-Pierfranceschi
authors.affiliation: Emergency Department, Guglielmo da Saliceto Hospital, Piacenza, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Magnacavallo
authors.affiliation: Radiology Unit, Guglielmo da Saliceto Hospital, Piacenza, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Michieletti
authors.affiliation: Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: John
authors.initials: J
authors.lastname: Morelli
authors.affiliation: Neurology Unit, Guglielmo da Saliceto Hospital, Via Taverna 49, 29121, Piacenza, Italy.
authors.forename: Donata
authors.initials: D
authors.lastname: Guidetti
mesh_terms: D000368:Aged; D001921:Brain / Q000000981:diagnostic imaging*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D020300:Intracranial Hemorrhages / Q000209:etiology; D008297:Male; D018579:Patient Selection; D010477:Perfusion / Q000379:methods; D010865:Pilot Projects; D020521:Stroke / Q000188:drug therapy*; D015912:Thrombolytic Therapy; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D036542:Tomography, Spiral Computed
chemical_list: D010959:Tissue Plasminogen Activator
keywords: CT perfusion; Penumbra; Wake-up stroke