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Stroke complicAtions After TraUmatic expeRieNces and Stress

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03496480
Acronym
SATURN
Enrollment
636
Registered
2018-04-12
Start date
2018-04-15
Completion date
2019-07-01
Last updated
2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

ptsd, stress, traumatization

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTQuestionnaires

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

Sponsors

Johanna Schöner
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients treated at the Charité Medical Center for acute ischemic stroke 2. Confirmation of diagnosis by CT or MRI 3. Age \> 18 years 4. Ability to give informed consent

Exclusion criteria

1. Stroke secondary to complications from an intracranial aneurysm, arterial-venous malformation, intracranial tumor or neoplastic process 2. 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 2\. Severe comprehension deficits, e.g. severe aphasia, dementia 3. Substantial pre-stroke disability (e.g. from a previous stroke)

Design outcomes

Primary

MeasureTime frameDescription
Stroke-induced PTSD9-13 months after strokeStroke-induced PTSD will be measured using the Impact of Event Scale - Revised (IES-R).

Secondary

MeasureTime frameDescription
Trauma exposure9-13 months after strokePrior trauma exposure before the infarct is ascertained with the 10-item Brief Trauma Questionnaire (BTQ).
Lifetime PTSD9-13 months after strokeThe occurrence of PTSD symptoms in the study subjects' lifetimes is assessed using the 7-item Short Screening Scale for DSM IV PTSD.
Functional outcome9-13 months after strokeFunctional outcome is measured with the SF-36

Other

MeasureTime frameDescription
Depression9-13 months after strokedepressive symptoms are assessed with the BDI (Beck's Depression Inventory)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026