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Prospective Cohort With Incident Stroke (PROSCIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Ludwig-Maximilians - University of Munich
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Martin Dichgans, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01364168
First received: May 31, 2011
Last updated: December 6, 2011
Last verified: December 2011

May 31, 2011
December 6, 2011
February 2011
December 2015   (final data collection date for primary outcome measure)
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01364168 on ClinicalTrials.gov Archive Site
  • Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
 
Prospective Cohort With Incident Stroke
Prospective Cohort With Incident Stroke

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum, RNA

Probability Sample

Patients admitted to a specialized stroke service because of an acute stroke

Ischemic Stroke
Not Provided
First ever acute ischemic 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.
 
Recruiting
850
December 2018
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Martin Dichgans, Prof. +49 (0)89 7095 ext 8310 martin.dichgans@med.uni-muenchen.de
Germany
 
NCT01364168
ISD-PROSCIS-01
No
Martin Dichgans, Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
Charite University, Berlin, Germany
Study Chair: Martin Dichgans, Prof. Institute for Stroke and Dementia Research, Klinikum der Universität München, Campus Großhadern
Ludwig-Maximilians - University of Munich
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP