Prospective Cohort With Incident Stroke

Ischemic Stroke Clinical Trial

— PROSCIS  

Official title:

Prospective Cohort With Incident Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01364168
• Other study ID #: ISD-PROSCIS-01
• Status: Recruiting
• Start date: February 2011
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Ludwig-Maximilians - University of Munich
• Contact: Martin Dichgans, Prof.
• Phone: +49 (0)89 4400
• Email: martin.dichgans[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 3, 12, 24 and 36 months.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Germany	Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin	Berlin
Germany	Interdisciplinary Stroke Center Munich, Klinikum der Universität München	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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/jou — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death	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	Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death	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
Secondary	Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death	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
Secondary	Course of cognitive function	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
Secondary	Course of depression	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

External Links

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