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
  Purpose

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.


Condition
Ischemic Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort With Incident Stroke

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

whole blood, serum, RNA


Estimated Enrollment: 850
Study Start Date: February 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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 prospective CSB-stroke cohort.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364168

Contacts
Contact: Martin Dichgans, Prof. +49 (0)89 7095 ext 8310 martin.dichgans@med.uni-muenchen.de

Locations
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   
Principal Investigator: Peter U. Heuschmann, Prof.         
Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern Recruiting
Munich, Germany, 81377
Contact: Martin Dichgans, MD    +49 (0)89 7095 ext 8310    martin.dichgans@med.uni-muenchen.de   
Principal Investigator: Martin Dichgans, Prof.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Charite University, Berlin, Germany
Investigators
Study Chair: Martin Dichgans, Prof. Institute for Stroke and Dementia Research, Klinikum der Universität München, Campus Großhadern
  More Information

Additional Information:
No publications provided by Ludwig-Maximilians - University of Munich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin Dichgans, Prof., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01364168     History of Changes
Other Study ID Numbers: ISD-PROSCIS-01
Study First Received: May 31, 2011
Last Updated: December 6, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014