Clinical trial NCT01364168: Prospective Cohort With Incident Stroke
Official title: Prospective Cohort With Incident Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2011-06-02
Enrollment: 850
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 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.

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

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
Study officials:
affiliation: Institute for Stroke and Dementia Research, Klinikum der Universität München
name: Martin Dichgans, Prof.
role: STUDY_CHAIR
References:
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.
citation: 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.