Stroke complicAtions After TraUmatic expeRieNces and Stress (SATURN)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Diagnostic test: Questionnaires

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.

• Study Type: Observational
• Enrollment (Actual): 636

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated at the Charité Medical Center for acute ischemic stroke (9-13 months after stroke)

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke-induced PTSD	Stroke-induced PTSD will be measured using the Impact of Event Scale - Revised (IES-R).	9-13 months after stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trauma exposure	Prior trauma exposure before the infarct is ascertained with the 10-item Brief Trauma Questionnaire (BTQ).	9-13 months after stroke
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
Functional outcome	Functional outcome is measured with the SF-36	9-13 months after stroke

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	depressive symptoms are assessed with the BDI (Beck's Depression Inventory)	9-13 months after stroke

Collaborators and Investigators

• Sponsor: Johanna Schöner

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: stress; ptsd; traumatization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: EA2/113/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No