Prospective Cohort With Incident Stroke (PROSCIS)

Ludwig Maximilian University of Munich

Status: Enrolling

Conditions: Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT01364168

ISD-PROSCIS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 850 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

850 participants in 1 patient group

First ever acute ischemic stroke

Description:

Patients over 18 years and without prior stroke according to WHO criteria, displaying an ischemic stroke, onset within the last 7 days, language German