Prospective Cohort With Incident Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 3, 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 prospective CSB-stroke cohort.
Primary outcome measures
- Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [Time frame: 36 months]
Secondary outcome measures (4)
- Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [Time frame: 24 months]
- Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [Time frame: 12 months]
- Course of cognitive function [Time frame: 36 months]
- Course of depression [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Language: German
- First ever acute ischemic stroke 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 criteria)
- Patients presenting brain tumour or brain metastasis
- Participation in an intervention- / AMG-study
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 · 2 centers
- Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin — Berlin
- Interdisciplinary Stroke Center Munich, Klinikum der Universität München — Munich
Publications
- 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
- Malsch C, Liman T, Wiedmann S, Siegerink B, Georgakis MK, Tiedt S, Endres M, Heuschmann PU. Outcome after stroke attributable to baseline factors-The PROSpective Cohort with Incident Stroke (PROSCIS). PLoS One. 2018 Sep 26;13(9):e0204285. doi: 10.1371/journal.pone.0204285. eCollection 2018. PMID 30256828
Identifiers
NCT: NCT01364168 · ISD-PROSCIS-01