Clinical trial NCT03496480: Stroke complicAtions After TraUmatic expeRieNces and Stress
Official title: Stroke complicAtions After TraUmatic expeRieNces and Stress - a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: ptsd
stress
traumatization
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated at the Charité Medical Center for acute ischemic stroke (9-13 months after stroke)

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Stroke-induced PTSD
timeFrame: 9-13 months after stroke
Secondary outcomes:
measure: Trauma exposure
timeFrame: 9-13 months after stroke
measure: Lifetime PTSD
timeFrame: 9-13 months after stroke
measure: Functional outcome
timeFrame: 9-13 months after stroke
Other outcomes:
measure: Depression
timeFrame: 9-13 months after stroke
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
References: