Prospective Cohort With Incident Stroke

NCT ID: NCT01364168

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Martin Dichgans

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Dichgans, Prof.

Role: STUDY_CHAIR

Institute for Stroke and Dementia Research, Klinikum der Universität München

Locations

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Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Interdisciplinary Stroke Center Munich, Klinikum der Universität München

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Dichgans, Prof.

Role: CONTACT

+49 (0)89 4400 ext. 46019

Facility Contacts

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Martin Dichgans, Prof.

Role: primary

+49 (0)89 4400 ext. 46019

References

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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.

Reference Type BACKGROUND
PMID: 22928669 (View on PubMed)

Malsch C, Liman T, Wiedmann S, Siegerink B, Georgakis MK, Tiedt S, Endres M, Heuschmann PU. Outcome after stroke attributable to baseline factors-The PROSpective Cohort with Incident Stroke (PROSCIS). PLoS One. 2018 Sep 26;13(9):e0204285. doi: 10.1371/journal.pone.0204285. eCollection 2018.

Reference Type RESULT
PMID: 30256828 (View on PubMed)

Other Identifiers

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ISD-PROSCIS-01

Identifier Type: -

Identifier Source: org_study_id

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