Prospective Cohort With Incident Stroke

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT01364168
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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.

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 850

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death	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.

Secondary Outcome Measures

Name	Time	Method
Course of depression	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.
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death	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.
Course of cognitive function	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.

Trial Locations

Locations (2)

Interdisciplinary Stroke Center Munich, Klinikum der Universität München; 🇩🇪 Munich, Germany

Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany