Stroke complicAtions After TraUmatic expeRieNces and Stress

Stroke Clinical Trial

— SATURN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496480
• Other study ID #: EA2/113/16
• Status: Completed
• Start date: April 15, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 636
• Est. completion date: July 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Johanna Schöner

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression	depressive symptoms are assessed with the BDI (Beck's Depression Inventory)	9-13 months after stroke
Primary	Stroke-induced PTSD	Stroke-induced PTSD will be measured using the Impact of Event Scale - Revised (IES-R).	9-13 months after stroke
Secondary	Trauma exposure	Prior trauma exposure before the infarct is ascertained with the 10-item Brief Trauma Questionnaire (BTQ).	9-13 months after stroke
Secondary	Lifetime PTSD	The occurrence of PTSD symptoms in the study subjects' lifetimes is assessed using the 7-item Short Screening Scale for DSM IV PTSD.	9-13 months after stroke
Secondary	Functional outcome	Functional outcome is measured with the SF-36	9-13 months after stroke