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

NCT07553650 | Not Yet Recruiting

• 2 other identifiers: DRKS0003977501KX2524
• Study Type: observational
• Target: 12,750
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Intracerebral Haemorrhage; Stroke Acute; Paediatric Stroke; Stroke; Ischemic Stroke

Keywords

Stroke; ischemic stroke; Intracerebral Hemorrhage; Paediatric Stroke; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Embolic Stroke; Thrombotic Stroke; Acute

Outcome Measures

Primary Outcomes (1)

• adaptive research platform addressing various and for the 3 groups different research questions

  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.

Study Arms (3)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Wuerzburg University Hospital: collaborator

Study Sites (12)

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Location

Charité University, Berlin, Germany

Berlin, State of Berlin, 10117, Germany

Location

Universität Bielefeld, Universitätsklinikum OWL, Evangelisches Klinikum Bethel gGmbH,

Bielefeld, 33617, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck

Lübeck, 23538, Germany

Location

Ludwig Maximilians Universität Klinikum

München, 81377, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

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Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood, PAX gene blood, residual tissue (e.g. thrombi)

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke; Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Embolic Stroke; Thrombotic Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Infarction; Ischemia; Necrosis

Study Officials

• Karen Gertz, Full professor, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Goetz Thomalla, Full professor, MD

  Universtätsklinikum Hamburg Eppendorf, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna-Luise Kanwisch

CONTACT

+49-152-22803863; j.kanwisch@uke.de

Claudia Kunze

CONTACT

c.kunze@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician/ Head of Research Group

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

DE (12)