Götz Thomalla1, Florent Boutitie2, Jochen B Fiebach2, Claus Z Simonsen2, Norbert Nighoghossian2, Salvador Pedraza2, Robin Lemmens2, Pascal Roy2, Keith W Muir2, Martin Ebinger2, Ian Ford2, Bastian Cheng2, Ivana Galinovic2, Tae-Hee Cho2, Josep Puig2, Vincent Thijs2, Matthias Endres2, Jens Fiehler2, Christian Gerloff2. 1. From the Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., B.C., C.G.) and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Germany; Service de Biostatistique, Hospices Civils de Lyon, France (F.B., P.R.); Université Lyon 1, Villeurbanne, France (F.B., P.R.); CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France (F.B., P.R.); Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., I.G., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology, Aarhus University Hospital, Denmark (C.Z.S.); Department of Neurology, Hospices Civils de Lyon, France (N.N., T.-H.C.); Department of Radiology, Institut de Diagnostic per la Image (IDI), Hospital Dr Josep Trueta, Institut d'Investgació Biomèdica de Girona (IDIBGI), Spain (S.P., J.P.); Department of Neurosciences, Experimental Neurology, KU Leuven-University of Leuven, VIB Center for Brain & Disease Research, and Department of Neurology, University Hospitals Leuven, Belgium (R.L.); Institute of Neuroscience and Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, United Kingdom; and Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia (V.T.). thomalla@uke.de. 2. From the Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., B.C., C.G.) and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Germany; Service de Biostatistique, Hospices Civils de Lyon, France (F.B., P.R.); Université Lyon 1, Villeurbanne, France (F.B., P.R.); CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France (F.B., P.R.); Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., I.G., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology, Aarhus University Hospital, Denmark (C.Z.S.); Department of Neurology, Hospices Civils de Lyon, France (N.N., T.-H.C.); Department of Radiology, Institut de Diagnostic per la Image (IDI), Hospital Dr Josep Trueta, Institut d'Investgació Biomèdica de Girona (IDIBGI), Spain (S.P., J.P.); Department of Neurosciences, Experimental Neurology, KU Leuven-University of Leuven, VIB Center for Brain & Disease Research, and Department of Neurology, University Hospitals Leuven, Belgium (R.L.); Institute of Neuroscience and Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, United Kingdom; and Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia (V.T.).
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: http://www.clinicaltrials.gov. Unique identifier: NCT01525290. URL: https://www.clinicaltrialsregister.eu. Unique identifier: 2011-005906-32.
RCT Entities:
BACKGROUND AND PURPOSE: We describe clinical and magnetic resonance imaging (MRI) characteristics of strokepatients 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 strokepatients 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 strokepatients 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 strokepatients with regards to clinical characteristics but are comparable in terms of MRI characteristics of lesion age. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01525290. URL: https://www.clinicaltrialsregister.eu. Unique identifier: 2011-005906-32.
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