Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort

NCT01363856 — Unknown, 750 participants, Charite University, Berlin, Germany

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RegistryNCT01363856, acronym CSB_PROSCIS
StatusUnknown
Study typeObservational
Enrollment750 (Estimated)
SponsorCharite University, Berlin, Germany (Other); collaborators: Klinikum der Universitaet Muenchen, Grosshadern
ConditionsStroke
Datesstart 2010-02-01, primary completion 2013-06-01 (estimated), completion 2015-06-01 (estimated), first posted 2011-06-02, last updated 2011-06-02
Locations2 sites in Germany

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-Summary

The primary aim of the study is to derive and validate risk scores for vascular endpoints (recurrent stroke, myocardial infarction, and other complications of stroke) and for death following an incident stroke. For this purpose patients with an incident stroke will be followed for 36 months with additional assessments at 12, 24 and 36 months.

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+Detailed description

Risk of vascular disease including stroke, myocardial infarction, and vascular death is high after stroke but there are only few prognostic models for long term risk up to 3 years. About 850 patients with an incident stroke will be followed for 3 years with assessments at baseline and at 3, 12, 24, and 36 months. Factors that have already been reported to be significant predictors of vascular diseases in previous studies as well as new biomarkers (e.g. neuroimaging, blood based biomarkers) identified in this cohort will be considered. The improvement of discrimination including these new variables in the models will be investigated. Several measures of improving predictive properties (e.g. calibration, discrimination, net reclassification) will be used to compare predictive models with different complexity. The model will be validated using the bootstrap method (internal validation) and an independent external sample in cooperation with the Institute for Stroke and Dementia Research, Munich.

+Arms and interventions

ArmTypeInterventionsDescription
First ever acute strokePatients over 18 years and without prior stroke according to WHO criteria, displaying an ischemic stroke, onset within the last 7 days, language German

+Outcome measures

Primary outcomes

  • Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [36 months]: This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by hospital or physician.

Secondary outcomes

  • Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [24 months]: This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by hospital or physician. In case of death of the patient, evaluation will be based on data from the registry office
  • Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [12 months]: This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by hospital or physician. In case of death of the patient, evaluation will be based on data from the registry office
  • Course of cognitive function [36 months]: This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by the physician
  • Course of depression [36 months]: This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by the physician

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥18 years
* Language: German
* First ever stroke including ischemic stroke, primary intracranial hemorrhage and cerebral venous sinus thrombosis that occurred with stroke onset in the last 7 days
* Written informed consent by patient prior to study participation
* Willingness to participate in follow-up

Exclusion Criteria:

* Prior stroke (definition according to WHO definition)
* Patients presenting brain tumour or brain metastasis
* Participation in an intervention- / AMG-study

+Locations (2)

FacilityCityCountryStatus
Center for Stroke Research Berlin, Charité Universitätsmedizin BerlinBerlin, State of BerlinGermanyRecruiting
Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus GroßhadernMunichGermanyRecruiting

+Publications

  • Results publication: Kufner A, Tang Y, Temuulen U, Abbas G, Rackoll T, Grittner U, Kroneberg D, Weigl B, Kuhn AA, Reich M, Nave AH, Endres M. Who Falls After a Stroke? Evidence From a Prospective Stroke Cohort. Eur J Neurol. 2026 Jun;33(6):e70678. doi: 10.1111/ene.70678. PMID 42340058
  • Results publication: Gronewold J, Hagemann N, Zhang Y, Jung M, Fleischer M, Mohamud Yusuf A, Li A, Wang C, Dzyubenko E, Scholtysik R, Klein-Hitpass L, Kraus A, Tuz AA, Singh V, Frank B, Monig A, Giese A, Graser C, Niklas EM, da Silva Rafael M, Nanthagopal M, Neumann J, Kufner A, Liman TG, Liu Y, Minnerup J, Klotz L, Giebel B, Tertel T, Endres M, Hermann DM, Gunzer M. CD177 Expression on Neutrophils Predicts Ischemic Stroke Outcome in Humans. Stroke. 2026 May;57(5):1283-1297. doi: 10.1161/STROKEAHA.125.054673. Epub 2026 Feb 26. PMID 41744081
  • Results publication: Giesers NK, Schaeff V, Gertz K, Endres M, Liman TG. Associations of Soluble Inflammatory and Endothelial Activation Biomarkers with Cognitive Function Over Three Years After Ischemic Stroke-PROSCIS-B. Transl Stroke Res. 2025 Dec;16(6):2249-2257. doi: 10.1007/s12975-025-01388-4. Epub 2025 Oct 8. PMID 41057606
  • Results publication: Rios AS, Temuulen U, Khalil AA, Villringer K, Ali HF, Akdeniz A, Grittner U, Becher M, Rackoll T, Nave AH, Sperber PS, Liman TG, Otte C, Endres M, Kufner A. Lesion-Network Mapping of Poststroke Depressive Symptoms: Evidence From Two Prospective Ischemic Stroke Cohorts. Stroke. 2025 Sep;56(9):2527-2539. doi: 10.1161/STROKEAHA.125.051858. Epub 2025 Jul 7. PMID 40620229
  • Results publication: Liman TG, Siegerink B, Piper S, Catar R, Moll G, Riemekasten G, Heidecke H, Heuschmann PU, Elkind MSV, Dragun D, Endres M. Vasoregulatory Autoantibodies and Clinical Outcome After Ischemic Stroke-PROSCIS-B. J Am Heart Assoc. 2023 Dec 5;12(23):e032441. doi: 10.1161/JAHA.123.032441. Epub 2023 Nov 28. PMID 38014691
  • Results publication: Schaeff VLK, Sperber PS, Piper SK, Giesers NK, Gertz K, Heuschmann PU, Endres M, Liman TG. Associations of C-reactive protein with depressive symptoms over time after mild to moderate ischemic stroke in the PROSCIS-B cohort. J Neurol. 2024 Feb;271(2):909-917. doi: 10.1007/s00415-023-12038-w. Epub 2023 Oct 18. PMID 37848651
  • Results publication: Stillfried MRV, Sperber PS, Broersen LHA, Huo S, Piper SK, Heuschmann PU, Endres M, Siegerink B, Liman TG. Low ankle-brachial index and cognitive function after stroke-the PROSpective with Incident Stroke Berlin (PROSCIS-B). Front Neurol. 2022 Sep 28;13:963262. doi: 10.3389/fneur.2022.963262. eCollection 2022. PMID 36247749
  • Results publication: Scheitz JF, Lim J, Broersen LHA, Ganeshan R, Huo S, Sperber PS, Piper SK, Heuschmann PU, Audebert HJ, Nolte CH, Siegerink B, Endres M, Liman TG. High-Sensitivity Cardiac Troponin T and Recurrent Vascular Events After First Ischemic Stroke. J Am Heart Assoc. 2021 May 18;10(10):e018326. doi: 10.1161/JAHA.120.018326. Epub 2021 May 13. PMID 33982599
  • Results publication: Huo S, Krankel N, Nave AH, Sperber PS, Rohmann JL, Piper SK, Heuschmann PU, Landmesser U, Endres M, Siegerink B, Liman TG. Endothelial and Leukocyte-Derived Microvesicles and Cardiovascular Risk After Stroke: PROSCIS-B. Neurology. 2021 Feb 9;96(6):e937-e946. doi: 10.1212/WNL.0000000000011223. Epub 2020 Nov 12. PMID 33184230
  • Results publication: Broersen LHA, Siegerink B, Sperber PS, von Rennenberg R, Piper SK, Nolte CH, Heuschmann PU, Endres M, Scheitz JF, Liman TG. High-Sensitivity Cardiac Troponin T and Cognitive Function in Patients With Ischemic Stroke. Stroke. 2020 May;51(5):1604-1607. doi: 10.1161/STROKEAHA.119.028410. Epub 2020 Apr 13. PMID 32279621
  • Results publication: Sperber PS, Siegerink B, Huo S, Rohmann JL, Piper SK, Pruss H, Heuschmann PU, Endres M, Liman TG. Serum Anti-NMDA (N-Methyl-D-Aspartate)-Receptor Antibodies and Long-Term Clinical Outcome After Stroke (PROSCIS-B). Stroke. 2019 Nov;50(11):3213-3219. doi: 10.1161/STROKEAHA.119.026100. Epub 2019 Sep 17. PMID 31526121
  • Results publication: Liman TG, Zietemann V, Wiedmann S, Jungehuelsing GJ, Endres M, Wollenweber FA, Wellwood I, Dichgans M, Heuschmann PU. Prediction of vascular risk after stroke - protocol and pilot data of the Prospective Cohort with Incident Stroke (PROSCIS). Int J Stroke. 2013 Aug;8(6):484-90. doi: 10.1111/j.1747-4949.2012.00871.x. Epub 2012 Aug 29. PMID 22928669

+Investigators