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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease
Stroke

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort
Study Start Date : February 2010
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2015
Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Biospecimen Retention:   Samples With DNA
Samples with DNA whole blood, serum, RNA

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to a specialized stroke service because of an acute stroke
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363856


Contacts
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Contact: Peter U Heuschmann, MD, MPH 0049 (0)30 450560611 peter.heuschmann@charite.dwe
Contact: Thomas G Liman, MD 49 (0)30 450560643 thomas.liman@charite.de

Locations
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Germany
Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Peter U Heuschmann, MD, MPH    +49 (0)30 450560611    peter.heuschmann@charite.de   
Contact: Thomas G Liman, MD    +49 (0)30 450560643    thomas.liman@charite.de   
Principal Investigator: Peter U Heuschmann, MD, MPH         
Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern Recruiting
Munich, Germany
Contact: Martin Dichgans, MD    +49 (0)89 7095 Ext. 8310    martin.dichgans@med.uni-muenchen.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Klinikum der Universitaet Muenchen, Grosshadern
Investigators
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Principal Investigator: Peter U Heuschmann, MD MPH Center for Stroke Research Berlin, Charité Campus Mitte
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Matthias Endres, MD, Center for Stroke Research Berlin
ClinicalTrials.gov Identifier: NCT01363856    
Other Study ID Numbers: CSB_PROSCIS_01
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: May 2011
Keywords provided by Charite University, Berlin, Germany:
first ever stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases