Stroke-CORE: master study protocol of the national cohort of the specialty network stroke within the network university medicine in Germany

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).

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Journal
Neurological Research and Practice
Published
2026-10-30
DOI
https://doi.org/10.1186/s42466-026-00547-8
Primary Topic
Acute Ischemic Stroke Management
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article
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article

Stroke-CORE: master study protocol of the national cohort of the specialty network stroke within the network university medicine in Germany

Markus Wagner, Katharina Feil, Christian Grefkes, Folke Brinkmann et al.
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Neurological Research and Practice
Acute Ischemic Stroke Management
article

Stroke-CORE: master study protocol of the national cohort of the specialty network stroke within the network university medicine in Germany

Markus Wagner, Katharina Feil, Christian Grefkes, Folke Brinkmann, Jan Christoph Purrucker, Götz Thomalla, Christian Otte, Martin Bendszus, Christian Hans Nolte, Bastian Cheng, Peter Ulrich Heuschmann, Anna Kopczak, Claudia Kunze, Mark Dzietko, Dominik Michalski, Agnes Flöel, Lucia Kerti, Martin Köhrmann, Stefan Schwab, Timo Uphaus, Annerose Mengel, Christina Franzisket, Kristina Szabo, Dorothee Saur, Jennifer Linn, Jessica Barlinn, Lucia Gerstl, Jens Minnerup, Steffi Jírů-Hillmann, Karen R. Gertz, Heinrich J. Audebert, Angelika Alonso, Rolf Wachter, Wolf‐Rüdiger Schäbitz, Flora Noelle Wiegand, Kai Günther, Johanna-Luise Kanwisch, Kathrin Harringa
article en

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).

Neurological Research and PracticeVol. 8(1)
Johannes Gutenberg University Mainz (DE), Bielefeld University (DE), Heidelberg University (DE), Universitätsmedizin Greifswald (DE), German Center for Neurodegenerative Diseases (DE), University Hospital Heidelberg (DE), LMU Klinikum (DE), Universitätsklinikum Erlangen (DE), Düsseldorf University Hospital (DE), Universitätsklinikum Tübingen (DE), University Medical Center Hamburg-Eppendorf (DE), University Hospital Schleswig-Holstein (DE), Essen University Hospital (DE), University Hospital Leipzig (DE), Universitätsklinikum Würzburg (DE), German Centre for Cardiovascular Research (DE), University Hospital Frankfurt (DE), University Hospital Ulm (DE), University Hospital Carl Gustav Carus (DE), Stiftung Deutsche Schlaganfall-Hilfe (DE), Institut für Schlaganfall- und Demenzforschung (DE), Technische Universität Dresden (DE), Charité - Universitätsmedizin Berlin (DE), Ludwig-Maximilians-Universität München (DE), University of Lübeck (DE)
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Openalex Percentile: Top 12%
Acute Ischemic Stroke Management
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