Stroke
Conditions
Keywords
first ever 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.
Interventions
None listed
Sponsors
Klinikum der Universitaet Muenchen, Grosshadern
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Germany
Contacts
Primary ContactPeter U Heuschmann, MD, MPH
Backup ContactThomas G Liman, MD
Outcome results
None listed