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

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.

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.

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.

The protocol is registered at German Clinical Trials Register (DRKS00039775, July 8th, 2026).