Stroke-CORE: master study protocol of the national cohort of the specialty network stroke within the network university medicine in Germany
Year: 2026
Type: article
Study design: Study Protocol
Abstract: INTRODUCTION: Although Germany has a strong history of stroke research, it currently lacks a national harmonised infrastructure for clinical stroke research. To address this gap, the stroke-specific Specialty Network (SN Stroke) of the Network University Medicine (NUM) was established as a comprehensive research platform. Hereby we present the protocol of the Stroke-CORE cohort (COhort for REsearch in Stroke) within SN Stroke enrolling a large representative cohort of patients with acute ischeamic stroke or intracerebral haemorrhage in Germany. METHODS: Stroke-CORE is a national, prospective, longitudinal, multi-centre cohort study with a decentralised biobank, structured as a modular umbrella protocol. Adult patients with acute ischaemic stroke or intracerebral haemorrhage, and paediatric stroke patients are enrolled at participating hospitals. Data collection follows four adaptive levels, ranging from a core clinical data set (Level 1) to modules covering the whole stroke care pathway (Level 2), biosamples (Level 3), and voluntary additional modules (Level 4), with follow-up at discharge, 90 days, 180 days (optional), and annually. Enrolment started in August 2026 across 12 initial sites, with a target of 12,750 patients being recruited by 2030. PERSPECTIVE: Stroke-CORE represents a nationally harmonised cohort spanning prehospital care, acute treatment, rehabilitation, prevention, aftercare, and paediatric stroke. Its adaptive modular design allows continuous expansion with new modules, data streams, and biobanking initiatives without protocol revision. As a sustainable national research platform, Stroke-CORE aims to address key knowledge gaps, facilitate recruitment for clinical trials, and accelerate translational, clinical and outcomes research. TRIAL REGISTRATION: The protocol is registered at German Clinical Trials Register (DRKS00039775, July 8th, 2026).
Authors: Flora Noelle Wiegand, Angelika Alonso, Heinrich J. Audebert, Jessica Barlinn, Martin Bendszus, Folke Brinkmann, Bastian Cheng, Mark Dzietko, Katharina Feil, Agnes Flöel, Christina Franzisket, Lucia Gerstl, Christian Grefkes, Kai Günther, Kathrin Harringa, Steffi Jiru-Hillmann, Johanna-Luise Kanwisch, Lucia Kerti, Martin Köhrmann, Anna Kopczak, Claudia Kunze, Jennifer Linn, Annerose Mengel, Dominik Michalski, Jens Minnerup, Christian H. Nolte, Christian Otte, Jan Purrucker, Dorothee Saur, Wolf Schäbitz, Stefan Schwab, Kristina Szabo, Timo Uphaus, Rolf Wachter, Markus Wagner, Peter U. Heuschmann, Karen Gertz, Götz Thomalla
Institutions: Universitätsklinikum Würzburg, Heidelberg University, Charité – Universitätsmedizin Berlin, University Hospital Carl Gustav Carus, Technische Universität Dresden, University Hospital Heidelberg, University Hospital Schleswig-Holstein, University Medical Center Hamburg-Eppendorf, Düsseldorf University Hospital, University Hospital Ulm, Universitätsmedizin Greifswald, German Center for Neurodegenerative Diseases, Stiftung Deutsche Schlaganfall-Hilfe, LMU Klinikum, Ludwig-Maximilians-Universität München, University Hospital Frankfurt, Essen University Hospital, Institut für Schlaganfall- und Demenzforschung, Universitätsklinikum Tübingen, University Hospital Leipzig, German Centre for Cardiovascular Research, University of Lübeck, Bielefeld University, Universitätsklinikum Erlangen, Johannes Gutenberg University Mainz
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,190
OpenAlex ID: W7224911998