Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort

NCT ID: NCT01363856

Last Updated: 2011-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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First ever acute stroke

Patients over 18 years and without prior stroke according to WHO criteria, displaying an ischemic stroke, onset within the last 7 days, language German

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinikum der Universitaet Muenchen, Grosshadern

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Center for Stroke Research Berlin

Principal Investigators

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Peter U Heuschmann, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Center for Stroke Research Berlin, Charité Campus Mitte

Locations

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Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Peter U Heuschmann, MD, MPH

Role: CONTACT

0049 (0)30 450560611

Thomas G Liman, MD

Role: CONTACT

49 (0)30 450560643

Facility Contacts

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Peter U Heuschmann, MD, MPH

Role: primary

+49 (0)30 450560611

Thomas G Liman, MD

Role: backup

+49 (0)30 450560643

Martin Dichgans, MD

Role: primary

+49 (0)89 7095 Ext. 8310

References

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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 Oct 8. doi: 10.1007/s12975-025-01388-4. Online ahead of print.

Reference Type DERIVED
PMID: 41057606 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40620229 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38014691 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37848651 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36247749 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33982599 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33184230 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32279621 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31526121 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22928669 (View on PubMed)

Related Links

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http://www.strokecenter.de

Center for Stroke Research Berlin

Other Identifiers

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CSB_PROSCIS_01

Identifier Type: -

Identifier Source: org_study_id

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