PREDICT-juvenile-stroke: PRospective evaluation of a prediction score determining individual clinical outcome three months after ischemic stroke in young adults – a study protocol
Sonja Schönecker,
Verena Hoffmann,
Fady Albashiti,
Reinhard Thasler,
Marlien Hagedorn,
Marie-Luise Louiset,
Anna Kopczak,
Jennifer Rösler,
Enayatullah Baki,
Silke Wunderlich,
Florian Kohlmayer,
Klaus Kuhn,
Martin Boeker,
Johannes Tünnerhoff,
Sven Poli,
Ulf Ziemann,
Oliver Kohlbacher,
Katharina Althaus,
Susanne Müller,
Albert Ludolph,
Hans A. Kestler,
Ulrich Mansmann,
Marianne Dieterich,
Lars Kellert
Affiliations
Sonja Schönecker
Department of Neurology, Ludwig-Maximilians-Universität München
Verena Hoffmann
Institute for Medical Informatics, Biometry, and Epidemiology, Ludwig-Maximilians-Universität München
Fady Albashiti
Center for Medical Data Integration and Analysis, Ludwig-Maximilians-Universität München
Reinhard Thasler
Center for Medical Data Integration and Analysis, Ludwig-Maximilians-Universität München
Marlien Hagedorn
Center for Medical Data Integration and Analysis, Ludwig-Maximilians-Universität München
Marie-Luise Louiset
Institute of Laboratory Medicine, Ludwig-Maximilians-Universität München
Anna Kopczak
Institute for Stroke and Dementia Research (ISD), Ludwig-Maximilians-Universität München
Jennifer Rösler
Department of Neurology, School of Medicine, Klinikum rechts der Isar, Technical University of Munich
Enayatullah Baki
Department of Neurology, School of Medicine, Klinikum rechts der Isar, Technical University of Munich
Silke Wunderlich
Department of Neurology, School of Medicine, Klinikum rechts der Isar, Technical University of Munich
Florian Kohlmayer
Institute of Medical Informatics, Statistics and Epidemiology, University Hospital rechts der Isar of the Technical University Munich
Klaus Kuhn
Institute of Medical Informatics, Statistics and Epidemiology, University Hospital rechts der Isar of the Technical University Munich
Martin Boeker
Institute of Medical Informatics, Statistics and Epidemiology, University Hospital rechts der Isar of the Technical University Munich
Johannes Tünnerhoff
Department of Neurology & Stroke, Eberhard Karls University Tübingen
Sven Poli
Department of Neurology & Stroke, Eberhard Karls University Tübingen
Ulf Ziemann
Department of Neurology & Stroke, Eberhard Karls University Tübingen
Oliver Kohlbacher
Department of Computer Science, Center for Bioinformatics and Quantitative Biology Center, Eberhard-Karls-University Tübingen
Katharina Althaus
Department of Neurology, University of Ulm
Susanne Müller
Department of Neurology, University of Ulm
Albert Ludolph
Department of Neurology, University of Ulm
Hans A. Kestler
Intitute of Medical Systems Biology, University of Ulm
Ulrich Mansmann
Institute for Medical Informatics, Biometry, and Epidemiology, Ludwig-Maximilians-Universität München
Marianne Dieterich
Department of Neurology, Ludwig-Maximilians-Universität München
Lars Kellert
Department of Neurology, Ludwig-Maximilians-Universität München
Abstract Background Although of high individual and socioeconomic relevance, a reliable prediction model for the prognosis of juvenile stroke (18–55 years) is missing. Therefore, the study presented in this protocol aims to prospectively validate the discriminatory power of a prediction score for the 3 months functional outcome after juvenile stroke or transient ischemic attack (TIA) that has been derived from an independent retrospective study using standard clinical workup data. Methods PREDICT-Juvenile-Stroke is a multi-centre (n = 4) prospective observational cohort study collecting standard clinical workup data and data on treatment success at 3 months after acute ischemic stroke or TIA that aims to validate a new prediction score for juvenile stroke. The prediction score has been developed upon single center retrospective analysis of 340 juvenile stroke patients. The score determines the patient’s individual probability for treatment success defined by a modified Rankin Scale (mRS) 0–2 or return to pre-stroke baseline mRS 3 months after stroke or TIA. This probability will be compared to the observed clinical outcome at 3 months using the area under the receiver operating characteristic curve. The primary endpoint is to validate the clinical potential of the new prediction score for a favourable outcome 3 months after juvenile stroke or TIA. Secondary outcomes are to determine to what extent predictive factors in juvenile stroke or TIA patients differ from those in older patients and to determine the predictive accuracy of the juvenile stroke prediction score on other clinical and paraclinical endpoints. A minimum of 430 juvenile patients (< 55 years) with acute ischemic stroke or TIA, and the same number of older patients will be enrolled for the prospective validation study. Discussion The juvenile stroke prediction score has the potential to enable personalisation of counselling, provision of appropriate information regarding the prognosis and identification of patients who benefit from specific treatments. Trial registration The study has been registered at https://drks.de on March 31, 2022 ( DRKS00024407 ).