Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort

Stroke Clinical Trial

— CSB_PROSCIS  

Official title:

Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01363856
• Other study ID #: CSB_PROSCIS_01
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2011
• Last updated: June 1, 2011
• Start date: February 2010
• Est. completion date: June 2015

Study information

• Verified date: May 2011
• Source: Charite University, Berlin, Germany
• Contact: Peter U Heuschmann, MD, MPH
• Phone: 0049 (0)30 450560611
• Email: peter.heuschmann[@]charite.dwe
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission CharitéGermany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: June 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Germany	Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin	Berlin
Germany	Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Klinikum der Universitaet Muenchen, Grosshadern

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death	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.	36 months	No
Secondary	Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death	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	24 months	No
Secondary	Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death	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	12 months	No
Secondary	Course of cognitive function	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	36 months	No
Secondary	Course of depression	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	36 months	No

External Links

•   Center for Stroke Research Berlin