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Title: Stroke with unknown time of symptom onset: baseline clinical and magnetic resonance imaging data of the first thousand patients in WAKE-UP (efficacy and safety of MRI-Based thrombolysis in WAKE-UP stroke: a randomized, doubleblind, placebo-controlled trial)
Austin Authors: Thomalla, Gotz;Boutitie, Florent;Fiebach, Jochen B;Simonsen, Claus Z;Nighoghossian, Norbert;Pedraza, Salvador;Lemmens, Robin;Roy, Pascal;Muir, Keith W;Ebinger, Martin;Ford, Ian;Cheng, Bastian;Galinovic, Ivana;Cho, Tae-Hee;Puig, Josep;Thijs, Vincent;Endres, Matthias;Fiehler, Jens;Gerloff, Christian;WAKE-UP Investigators
Affiliation: Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, Universitätsklinikum Hamburg-Eppendorf, Germany
Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum, Universitätsklinikum Hamburg-Eppendorf, Germany
Service de Biostatistique, Hospices Civils de Lyon, France
Université Lyon 1, Villeurbanne, France
CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France
Centrum für Schlaganfallforschung Berlin (CSB), Charité-Universitätsmedizin Berlin, Germany
Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin, Germany
Department of Neurology, Aarhus University Hospital, Denmark
Department of Neurology, Hospices Civils de Lyon, France
Department of Radiology, Institut de Diagnostic per la Image (IDI), Hospital Dr Josep Trueta, Institut d'Investgació Biomèdica de Girona (IDIBGI), Spain
Department of Neurosciences, Experimental Neurology, KU Leuven-University of Leuven, VIB Center for Brain & Disease Research, and Department of Neurology, University Hospitals Leuven, Belgium
Institute of Neuroscience and Psychology, University of Glasgow, United Kingdom
Robertson Centre for Biostatistics, University of Glasgow, United Kingdom
Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia
Issue Date: Mar-2017 2017-02-17
Publication information: Stroke 2017; 48(3): 770-773
Abstract: BACKGROUND AND PURPOSE: We describe clinical and magnetic resonance imaging (MRI) characteristics of stroke patients with unknown time of symptom onset potentially eligible for thrombolysis from a large prospective cohort. METHODS: We analyzed baseline data from WAKE-UP (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke: A Randomized, Doubleblind, Placebo-Controlled Trial), an investigator-initiated, randomized, placebo-controlled trial of MRI-based thrombolysis in stroke patients with unknown time of symptom onset. MRI judgment included assessment of the mismatch between visibility of the acute ischemic lesion on diffusion-weighted imaging and fluid-attenuated inversion recovery. RESULTS: Of 1005 patients included, diffusion-weighted imaging and fluid-attenuated inversion recovery mismatch was present in 479 patients (48.0%). Patients with daytime-unwitnessed stroke (n=138, 13.7%) had a shorter delay between symptom recognition and hospital arrival (1.5 versus 1.8 hours; P=0.002), a higher National Institutes of Stroke Scale score on admission (8 versus 6; P<0.001), and more often aphasia (72.5% versus 34.0%; P<0.001) when compared with stroke patients waking up from nighttime sleep. Frequency of diffusion-weighted imaging and fluid-attenuated inversion recovery mismatch was comparable between both groups (43.7% versus 48.7%; P=0.30). CONCLUSIONS: Almost half of the patients with unknown time of symptom onset stroke otherwise eligible for thrombolysis had MRI findings making them likely to be within a time window for safe and effective thrombolysis. Patients with daytime onset unwitnessed stroke differ from wake-up stroke patients with regards to clinical characteristics but are comparable in terms of MRI characteristics of lesion age. CLINICAL TRIAL REGISTRATION: URL: Unique identifier: NCT01525290. URL: Unique identifier: 2011-005906-32.
DOI: 10.1161/STROKEAHA.116.015233
ORCID: 0000-0002-6614-8417
PubMed URL:
Type: Journal Article
Subjects: Aphasia
Informed consent
Magnetic Resonance Imaging
Risk Factors
Type of Clinical Study or Trial: Randomized Controlled Clinical Trial/Controlled Clinical Trial
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