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Prospective Cohort With Incident Stroke

Prospective Cohort With Incident Stroke

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01364168
Acronym
PROSCIS
Enrollment
850
Registered
2011-06-02
Start date
2011-02-28
Completion date
2027-12-31
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
CollaboratorOTHER
Ludwig-Maximilians - University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death36 monthsThis 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

MeasureTime frameDescription
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death24 monthsThis 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.
Course of cognitive function36 monthsThis evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by the physician.
Course of depression36 monthsThis evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by the physician.

Countries

Germany

Contacts

Primary ContactMartin Dichgans, Prof.
martin.dichgans@med.uni-muenchen.de+49 (0)89 4400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026