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临床试验/NCT03496480
NCT03496480已完成不适用

Stroke complicAtions After TraUmatic expeRieNces and Stress - a Retrospective Cohort Study

Johanna Schöner1 个研究点 分布在 1 个国家目标入组 636 人开始时间: 2018年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
636
试验地点
1
主要终点
Stroke-induced PTSD

研究概览

简要总结

The primary aim of this retrospective cohort study is to test the hypothesis that previous traumatization (long) before an ischemic stroke increases the degree of stroke-induced PTSD symptoms at 9-13 months after the stroke event. Secondary outcome parameters include quality of life and depression.

详细描述

Neuropsychiatric consequences of brain ischemia play a critical role in shaping long-term stroke outcome. Unfortunately, however, as of now, clinical research and clinical practice have not adequately addressed this growing challenge. A good case in point is posttraumatic stress disorder (PTSD). Previous trauma exposure and posttraumatic stress symptoms may increase the risk of cardiovascular events (Sumner et al., 2015). Moreover, unbeknownst to most clinical neurologists, a significant portion (approximately 25%) of their stroke patients develop symptoms of post-traumatic stress disorder (PTSD) within the first year post-event. PTSD-related symptoms after an acute coronary syndrome increase the risk of recurrent cardiac events and mortality (Edmondson et al., 2012). Similarly, stroke-induced PTSD has been linked with worse long term stroke outcome, in particular, recurrent stroke, greater disability, non-adherence to medications, and comorbidities (Goldfinger et al., 2014; Kronish et al., 2012).

For a period of 22 months, all stroke patients treated at the Charité Medical Center will be screened retrospectively 9-13 months after a first-ever ischemic stroke (~2000). All eligible patients will be contacted by mail 9-13 months after their hospital stay with the request that they complete the questionnaires. The mailing will also include an information statement, the consent form, as well as a stamped return envelope.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Stroke-induced PTSD

时间窗: 9-13 months after stroke

Stroke-induced PTSD will be measured using the Impact of Event Scale - Revised (IES-R).

次要结局

  • Trauma exposure(9-13 months after stroke)
  • Lifetime PTSD(9-13 months after stroke)
  • Functional outcome(9-13 months after stroke)

研究者

发起方
Johanna Schöner
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Johanna Schöner

study doctor

Charite University, Berlin, Germany

研究点 (1)

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