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Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort (CSB_PROSCIS)

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ClinicalTrials.gov Identifier: NCT01363856
Recruitment Status : Unknown
Verified May 2011 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : June 2, 2011
Last Update Posted : June 2, 2011
Sponsor:
Collaborator:
Klinikum der Universitaet Muenchen, Grosshadern
Information provided by:
Charite University, Berlin, Germany

May 31, 2011
June 2, 2011
June 2, 2011
February 2010
June 2013   (Final data collection date for primary outcome measure)
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [ Time Frame: 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.
Same as current
No Changes Posted
  • Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [ Time Frame: 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
  • Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [ Time Frame: 12 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 cognitive function [ Time Frame: 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
  • Course of depression [ Time Frame: 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
Same as current
Not Provided
Not Provided
 
Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort
Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Samples with DNA whole blood, serum, RNA
Probability Sample
Patients admitted to a specialized stroke service because of an acute stroke
Stroke
Not Provided
First ever acute stroke
Patients over 18 years and without prior stroke according to WHO criteria, displaying an ischemic stroke, onset within the last 7 days, language German
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
750
Same as current
June 2015
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01363856
CSB_PROSCIS_01
No
Not Provided
Not Provided
Matthias Endres, MD, Center for Stroke Research Berlin
Charite University, Berlin, Germany
Klinikum der Universitaet Muenchen, Grosshadern
Principal Investigator: Peter U Heuschmann, MD MPH Center for Stroke Research Berlin, Charité Campus Mitte
Charite University, Berlin, Germany
May 2011