Stroke complicAtions After TraUmatic expeRieNces and Stress

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03496480
• Date of registration: 05/04/2018
• Prospective Registration: Yes
• Primary sponsor: Johanna Schöner
• Public title: Stroke complicAtions After TraUmatic expeRieNces and Stress SATURN
• Scientific title: Stroke complicAtions After TraUmatic expeRieNces and Stress - a Retrospective Cohort Study
• Date of first enrolment: April 15, 2018
• Target sample size: 636
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03496480
• Study type: Observational

Countries of recruitment

Germany

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Diagnostic Test: Questionnaires

Primary Outcome(s)

Stroke-induced PTSD [Time Frame: 9-13 months after stroke]

Secondary Outcome(s)

Trauma exposure [Time Frame: 9-13 months after stroke]

Functional outcome [Time Frame: 9-13 months after stroke]

Lifetime PTSD [Time Frame: 9-13 months after stroke]

Secondary ID(s)

EA2/113/16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors