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NCT Number: NCT01364168

Prospective Cohort With Incident Stroke

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.

Recruiting

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death

    Time frame: 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 outcomes

  1. Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death

    Time frame: 24 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. In case of death of the patient, evaluation will be based on data from the registry office.

  2. Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death

    Time frame: 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.

  3. Course of cognitive function

    Time frame: 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.

  4. Course of depression

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Dichgans, Prof.

CONTACT

[email protected]

+49 (0)89 4400 ext. 46019

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Charite University, Berlin, Germany

Registry information

Acronym: PROSCIS

Important dates

Study start
2011
Primary completion
2024
Study completion
2027
First posted
Jun 2, 2011
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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