Skip to main content
OpenTrials
Completed

NCT Number: NCT03496480

Stroke complicAtions After TraUmatic expeRieNces and Stress

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients treated at the Charité Medical Center for acute ischemic stroke
  • Confirmation of diagnosis by CT or MRI
  • Age > 18 years
  • Ability to give informed consent

Exclusion criteria

  • Stroke secondary to complications from an intracranial aneurysm, arterial-venous malformation, intracranial tumor or neoplastic process
  • Major diseases at the time of the hospital stay that would be expected to obviate meaningful follow-up assessments such as life-threatening heart or respiratory failure, renal or hepatic failure, cancer
  • Severe comprehension deficits, e.g. severe aphasia, dementia 3. Substantial pre-stroke disability (e.g. from a previous stroke)

Treatment and study plan

Questionnaires

Diagnostic Test

Psychological questionnaires: BTQ, IES-R, 7-items-short Screening scale, BDI, SF-36

Primary outcomes

  1. Stroke-induced PTSD

    Time frame: 9-13 months after stroke

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

Secondary outcomes

  1. Trauma exposure

    Time frame: 9-13 months after stroke

    Prior trauma exposure before the infarct is ascertained with the 10-item Brief Trauma Questionnaire (BTQ).

  2. Lifetime PTSD

    Time frame: 9-13 months after stroke

    The occurrence of PTSD symptoms in the study subjects' lifetimes is assessed using the 7-item Short Screening Scale for DSM IV PTSD.

  3. Functional outcome

    Time frame: 9-13 months after stroke

    Functional outcome is measured with the SF-36

Other outcomes

  1. Depression

    Time frame: 9-13 months after stroke

    depressive symptoms are assessed with the BDI (Beck's Depression Inventory)

Sponsors and collaborators

Lead sponsor

Johanna Schöner

Other

Registry information

Official study title

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

Acronym: SATURN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 12, 2018
Registry last updated
Aug 22, 2019

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.

Published trials that share one or more normalized conditions with this study.