Prospective Cohort With Incident Stroke (PROSCIS)
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Purpose
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.
| Condition |
|---|
|
Ischemic Stroke |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Cohort With Incident Stroke |
- Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [ Time Frame: 36 months ] [ Designated as safety issue: No ]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.
- Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [ Time Frame: 24 months ] [ Designated as safety issue: No ]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.
- Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]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.
- Course of depression [ Time Frame: 36 months ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
whole blood, serum, RNA
| Estimated Enrollment: | 850 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients admitted to a specialized stroke service because of an acute stroke
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
Contacts and Locations| Contact: Martin Dichgans, Prof. | +49 (0)89 7095 ext 8310 | martin.dichgans@med.uni-muenchen.de |
| Germany | |
| Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin | Recruiting |
| Berlin, Germany, 10117 | |
| Contact: Peter U. Heuschmann, MD, MPH +49 (0)30 450560611 peter.heuschmann@charite.de | |
| Principal Investigator: Peter U. Heuschmann, Prof. | |
| Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern | Recruiting |
| Munich, Germany, 81377 | |
| Contact: Martin Dichgans, MD +49 (0)89 7095 ext 8310 martin.dichgans@med.uni-muenchen.de | |
| Principal Investigator: Martin Dichgans, Prof. | |
| Study Chair: | Martin Dichgans, Prof. | Institute for Stroke and Dementia Research, Klinikum der Universität München, Campus Großhadern |
More Information
Additional Information:
No publications provided
| Responsible Party: | Martin Dichgans, Prof., Ludwig-Maximilians - University of Munich |
| ClinicalTrials.gov Identifier: | NCT01364168 History of Changes |
| Other Study ID Numbers: | ISD-PROSCIS-01 |
| Study First Received: | May 31, 2011 |
| Last Updated: | December 6, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 21, 2013