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

Official title

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

Overview

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.

Primary outcome measures

• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 12 centers

• Universitätsklinikum Hamburg-Eppendorf (UKE) — Hamburg
• Charité University, Berlin, Germany — Berlin
• Universität Bielefeld, Universitätsklinikum OWL, Evangelisches Klinikum Bethel gGmbH, — Bielefeld
• Universitätsklinikum Carl Gustav Carus Dresden — Dresden
• Universitätsklinikum Erlangen — Erlangen
• Universitätsklinikum Essen — Essen
• Universitätsklinikum Heidelberg — Heidelberg
• Universitätsklinikum Leipzig — Leipzig
• … and 4 more centers

Publications

• Poli S, Grohmann C, Wenzel DA, Poli K, Tunnerhoff J, Nedelmann M, Fiehler J, Burghaus I, Lehmann M, Glauch M, Schadwinkel HM, Kalmbach P, Zeller J, Peters T, Eschenfelder C, Agostini H, Campbell BC, Fischer MD, Sykora M, Mac Grory B, Feltgen N, Kowarik M, Seiffge D, Strbian D, Albrecht M, Alzureiqi MS, Auffarth G, Bazner H, Behnke S, Berberich A, Bode F, Bohmann FO, Cheng B, Czihal M, Danyel LA, D PMID 38591748
• Uhe T, Wasser K, Weber-Kruger M, Schabitz WR, Kohrmann M, Brachmann J, Laufs U, Dichgans M, Gelbrich G, Petroff D, Prettin C, Michalski D, Kraft A, Etgen T, Schellinger PD, Soda H, Bethke F, Ertl M, Kallmunzer B, Grond M, Althaus K, Hamann GF, Mende M, Wagner M, Groschel S, Uphaus T, Groschel K, Wachter R; Find-AF 2 study group. Intensive heart rhythm monitoring to decrease ischemic stroke and sys PMID 37422010
• Rimmele DL, Schrage T, Brettschneider C, Engels A, Gerloff C, Harter M, Rosenkranz M, Schmidt H, Kriston L, Thomalla G. Rationale and design of an interventional study of cross-sectoral, coordinated treatment of stroke patients with patient-orientated outcome measurement (StroCare). Neurol Res Pract. 2021 Feb 2;3(1):7. doi: 10.1186/s42466-021-00107-2. PMID 33526148
• Stahl B, Darkow R, von Podewils V, Meinzer M, Grittner U, Reinhold T, Grewe T, Breitenstein C, Floel A. Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia: A Randomized Controlled Trial Protocol. Front Neurol. 2019 Oct 22;10:1089. doi: 10.3389/fneur.2019.01089. eCollection 2019. PMID 31695667
• NAKO. (2025). Level 3 Projekte - NAKO Gesundheitsstudie. Retrieved 19.01.2026 from https://nako.de/forschung/forschungsprojekte/level-3-projekte/
• Wachter R, Weber-Kruger M, Hamann GF, Kermer P, Liman J, Mende M, Seegers J, Wasser K, Groschel S, Uphaus T, Poppert H, Kohrmann M, Zabel M, Laufs U, Heuschmann PU, Conen D, Groschel K; Find-AFRANDOMISED Investigators and Coordinators. Long-Term Follow-up of Enhanced Holter-Electrocardiography Monitoring in Acute Ischemic Stroke. J Stroke. 2022 Jan;24(1):98-107. doi: 10.5853/jos.2021.01207. Epub 2 PMID 34911255
• Vanassche T, Lauw MN, Eikelboom JW, Healey JS, Hart RG, Alings M, Avezum A, Diaz R, Hohnloser SH, Lewis BS, Shestakovska O, Wang J, Connolly SJ. Risk of ischaemic stroke according to pattern of atrial fibrillation: analysis of 6563 aspirin-treated patients in ACTIVE-A and AVERROES. Eur Heart J. 2015 Feb 1;36(5):281-7a. doi: 10.1093/eurheartj/ehu307. Epub 2014 Sep 3. PMID 25187524
• Turc G, Hadziahmetovic M, Walter S, Churilov L, Larsen K, Grotta JC, Yamal JM, Bowry R, Katsanos AH, Zhao H, Donnan G, Davis SM, Hussain MS, Uchino K, Helwig SA, Johns H, Weber JE, Nolte CH, Kunz A, Steiner T, Sacco S, Ebinger M, Tsivgoulis G, Fassbender K, Audebert HJ. Comparison of Mobile Stroke Unit With Usual Care for Acute Ischemic Stroke Management: A Systematic Review and Meta-analysis. JAM PMID 35129584

Identifiers

NCT: NCT07553650 · DRKS00039775 · 01KX2524 · DRKS00039775

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗