Prospective Cohort With Incident Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 2
- 主要终点
- Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prior stroke (definition according to WHO criteria)
- •Patients presenting brain tumour or brain metastasis
- •Participation in an intervention- / AMG-study
结局指标
主要结局
Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death
时间窗: 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.
次要结局
- Course of depression(36 months)
- Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death(12 months)
- Course of cognitive function(36 months)
研究者
Martin Dichgans
Prof.
Ludwig-Maximilians - University of Munich