Prospective Cohort With Incident Stroke (PROSCIS)

March 18, 2024 updated by: Martin Dichgans, Ludwig-Maximilians - University of Munich
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Active, not recruiting
        • Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin
      • Munich, Germany, 81377
        • Recruiting
        • Interdisciplinary Stroke Center Munich, Klinikum der Universität München
        • Contact:
        • Principal Investigator:
          • Martin Dichgans, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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 the physician. In case of death of the patient, evaluation will be based on data from the registry office.
12 months
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.
36 months
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Charite University, Berlin, Germany

Investigators

  • Study Chair: Martin Dichgans, Prof., Institute for Stroke and Dementia Research, Klinikum der Universität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimated)

June 2, 2011

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISD-PROSCIS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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