Clinical trial NCT01363856: Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort
Official title: Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: first ever stroke
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Klinikum der Universitaet Muenchen, Grosshadern
First posted: 2011-06-02
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to a specialized stroke service because of an acute stroke

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death
timeFrame: 36 months
Secondary outcomes:
measure: Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death
timeFrame: 24 months
measure: Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death
timeFrame: 12 months
measure: Course of cognitive function
timeFrame: 36 months
measure: Course of depression
timeFrame: 36 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin
city: Munich
country: Germany
facility: Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern
Study officials:
affiliation: Center for Stroke Research Berlin, Charité Campus Mitte
name: Peter U Heuschmann, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.