Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke)(Stroke-CORE) (Stroke-CORE)

April 23, 2026 updated by: Karen Gertz, Charite University, Berlin, Germany

Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke) (Stroke-CORE)

The Stroke-CORE cohort aims to provide a comprehensive and up-to-date understanding of stroke care in Germany. To achieve this, patients are followed along the entire continuum of care-from initial management before hospital admission, through acute treatment, rehabilitation, and follow-up care, to the prevention of recurrent strokes. Strokes occurring in childhood are also included in this cohort study.

In addition, the study seeks to establish effective structures for the early identification and inclusion of patients in clinical research (screening). In this context, structured screening processes are being implemented across all levels of care at participating sites within the Network University Medicine (NUM), a collaboration of German university hospitals. At the same time, the cohort serves as a platform within this network to systematically address open research questions in various areas of stroke care and to support the targeted planning and conduct of future clinical studies.

The study includes patients with ischemic stroke (caused by a blocked blood vessel) or intracerebral hemorrhage (bleeding within the brain). Participation takes place in different thematic modules, each focusing on specific aspects of the disease course and its management. These modules address, among other topics, acute hospital treatment, measures to prevent recurrent strokes (secondary prevention), possible complications, pre-hospital care, rehabilitation, follow-up care, and long-term outcomes such as physical recovery, independence in daily life, and cognitive functions including memory and concentration.

As part of the study, a range of data is collected. This includes sociodemographic information (such as age and living situation) as well as medical data, for example on prior conditions, diagnoses, treatments, and comorbidities. In addition, patients' health status is assessed at multiple time points in order to better understand the course of the disease. Depending on the level of participation, data collection may be complemented by the collection of biological samples, such as blood. These are obtained either during routine clinical procedures or through simple, minimally burdensome (non-invasive) methods.

The study is structured into several levels that differ in the scope and depth of data collection. The basic level includes essential information, while higher levels involve more detailed assessments. In addition, some levels include the collection of biological samples, and there are optional supplementary modules in which patients may participate voluntarily. This tiered approach allows participation to be flexibly adapted to the individual situation while contributing to a nuanced and comprehensive understanding of stroke care.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

12750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Johanna-Luise Kanwisch
  • Phone Number: +49-152-22803863
  • Email: j.kanwisch@uke.de

Study Contact Backup

Study Locations

  • Germany
      • Bielefeld, Germany, 33617
        • Universität Bielefeld, Universitätsklinikum OWL, Evangelisches Klinikum Bethel gGmbH,
        • Principal Investigator:
          • Wolf-Ruediger Schaebitz
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus Dresden
        • Principal Investigator:
          • Hagen Huttner
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
        • Principal Investigator:
          • Stefan Schwab
      • Essen, Germany, 45147
        • Universitätsklinikum Essen
        • Principal Investigator:
          • Martin Koehrmann
        • Principal Investigator:
          • Simone Schwarz
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
        • Principal Investigator:
          • Jan Purrucker
        • Principal Investigator:
          • Christian Gille (Paediatrics)
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
        • Principal Investigator:
          • Dominik Michalski
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck
        • Principal Investigator:
          • Folke Brinkmann (Paediatrics)
      • München, Germany, 81377
        • Ludwig Maximilians Universität Klinikum
        • Principal Investigator:
          • Anna Kopczak
        • Principal Investigator:
          • Lucia Gerstl (Paediatrics)
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
        • Principal Investigator:
          • Annerose Mengel
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
        • Principal Investigator:
          • Christian Hametner
        • Principal Investigator:
          • Christoph Haertel (Paediatrics)
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf (UKE)
        • Contact:
        • Principal Investigator:
          • Goetz Thomalla
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10117
        • Charite University, Berlin, Germany
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karen Gertz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stroke patients with criteria defined in each individual Module (IS, ICH, peadiatric stroke) who are admitted to one of the participating university hospitals in Germany within 24 hours of symptom onset.

General inclusion and exclusion criteria:

  • Fulfilment of all inclusion and no exclusion criteria for at least one Module
  • Signed IC from patients capable of giving consent and understanding all content of the IC or IC of an appropriate patient representative, if patients are unable to provide consent themselves.

Description

Inclusion Criteria:

  • Diagnosis of AIS or ICH; the AIS diagnosis may be diagnosed clinically or radiologically (i.e., focal neurological impairment of sudden onset, lasting more than 24 hours and of presumed vascular origin, or with proof of cerebral ischaemia corresponding to the clinical symptoms in neuroimaging); for ICH diagnosis requires clinical symptoms and radiological diagnosis of ICH
  • Hospital admission <24h after symptom onset
  • Age 18+ years for the basic Modules AIS and ICH; age <18 years for the basic Module paediatric stroke patients
  • Informed consent: Signed IC from patients capable of giving consent and understanding all content of the IC or IC of an appropriate patient representative or deferred consent, if patients are unable to consent themselves
  • Additional inclusion criteria are defined by the individual Modules

Exclusion Criteria:

  • In-hospital stroke
  • TIA
  • SAH
  • Stroke as a complication of a medical procedure
  • Enrolment in a randomised placebo-controlled interventional trial
  • Already enrolled in the SN STROKE base cohort

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ischemic Stroke
This module aims to collect comprehensive, longitudinal data on patients with acute IS to characterise clinical and imaging-derived predictors of outcome. The module is embedded within the broader cohort framework (Level 1) and focuses specifically on causes of IS, treatment during the acute phase, as well as complications, and secondary prevention. Data collection and follow up measures is aligned with the routine collection of quality-assurance data from the German Stroke Registers Study Group ('Arbeitsgemeinschaft Deutschsprachiger Schlaganfall Register' [ADSR], https://www.schlaganfallregister.org) and the ICHOM Standard Set for Stroke (https://www.ichom.org/patient-centered-outcome-measure/stroke/).
Intracerebral Hemorrhage
This module aims to collect data on adult patients presenting with spontaneous intracerebral haemorrhage (ICH). Participants will be characterised regarding demographics, clinical factors, treatment, and imaging features, including haematoma size, location, expansion dynamics, and the presence of spot sign. The study will aim to identify baseline clinical and imaging predictors of in-hospital and 3-month mortality and functional independence, to explore subgroups with distinct prognostic trajectories, and to investigate associations between clinical presentation, imaging parameters, and post-stroke complications. These analyses will inform risk stratification, guide neuroprotective and acute management strategies, and support the development of tailored interventional approaches in ICH.
Paediatric Stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adaptive research platform addressing various and for the 3 groups different research questions
Time Frame: Depending on the group, outcome measures will be collected through study completion, primarily at baseline, follow-up at 3 and/or 6 months, and annually, with an average follow-up period expected to be 1 year.
Outcomes include disease severity, standard of care, complications, recurrent ischaemic or haemorrhagic stroke, burden and impact of disease and treatment on quality of life, functional outcome and survival at different time points. Since SN Stroke is an adaptive research platform addressing various research questions, additional outcomes and different determinants influencing these outcomes may be added in each module.
Depending on the group, outcome measures will be collected through study completion, primarily at baseline, follow-up at 3 and/or 6 months, and annually, with an average follow-up period expected to be 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

University Hospital Schleswig-Holstein
Universitätsklinikum Hamburg-Eppendorf
Wuerzburg University Hospital

Investigators

  • Principal Investigator: Karen Gertz, Full professor, MD, Charite University, Berlin, Germany
  • Principal Investigator: Goetz Thomalla, Full professor, MD, Universtätsklinikum Hamburg Eppendorf, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRKS00039775 (Registry Identifier: DRKS (Deutsches Register Klinischer Studien/German Clinical Trials Register))
  • 01KX2524 (Other Grant/Funding Number: Federal Ministry of Research, Technology and Space, Germany)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD-including medical, biosamples, and imaging data as well as their analysis results-will be shared under strict governance. Secondary use is managed through defined Dynamic Use & Access (DUA) procedures, aligned with the NUM Publication Policy and Terms of Use, ensuring recognition of contributing sites and researchers while maintaining high data protection standards.

Applications must be submitted via a central application platform offering all required information and application documents. The DUA procedure includes:

  • Application submission
  • Formal review
  • Technical, scientific, and methodological evaluation
  • Decision by the relevant UA Committees
  • Data provision via a data transfer office following approval of the application.

Data and biosamples are only released following rigorous review, ensuring compliance with ethical, legal, and data protection requirements. Use is limited to the analyses specified in the application.

IPD Sharing Time Frame

At the earliest, following the first interim analysis, which is currently scheduled for mid-2027. Subject to future funding opportunities, the study itself and data sharing is planned to be conducted over the long term.

IPD Sharing Access Criteria

Data, imaging data and biosamples of stroke patients may be requested by any natural or legal person. A request must be submitted in accordance with the procedures described above, must be scientifically justified, and must fit within the framework established by this protocol and, more importantly, the scope of the ICF signed by the patients in the study. Before data and biosamples of accepted applications are transferred, the applicant or someone from the application team must provide a positive vote or a waiver from the Ethics Committee responsible for the applicant.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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