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Stroke complicAtions After TraUmatic expeRieNces and Stress (SATURN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03496480
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Johanna Schöner, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment
Stroke 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.

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Study Type : Observational
Actual Enrollment : 636 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Stroke complicAtions After TraUmatic expeRieNces and Stress - a Retrospective Cohort Study
Actual Study Start Date : April 15, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : July 1, 2019

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


Primary Outcome Measures :
  1. Stroke-induced PTSD [ Time Frame: 9-13 months after stroke ]
    Stroke-induced PTSD will be measured using the Impact of Event Scale - Revised (IES-R).


Secondary Outcome Measures :
  1. Trauma exposure [ Time Frame: 9-13 months after stroke ]
    Prior trauma exposure before the infarct is ascertained with the 10-item Brief Trauma Questionnaire (BTQ).

  2. Lifetime PTSD [ Time Frame: 9-13 months after stroke ]
    The occurrence of PTSD symptoms in the study subjects' lifetimes is assessed using the 7-item Short Screening Scale for DSM IV PTSD.

  3. Functional outcome [ Time Frame: 9-13 months after stroke ]
    Functional outcome is measured with the SF-36


Other Outcome Measures:
  1. Depression [ Time Frame: 9-13 months after stroke ]
    depressive symptoms are assessed with the BDI (Beck's Depression Inventory)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated at the Charité Medical Center for acute ischemic stroke (9-13 months after stroke)
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496480


Locations
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Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Johanna Schöner

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Responsible Party: Johanna Schöner, study doctor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03496480    
Other Study ID Numbers: EA2/113/16
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johanna Schöner, Charite University, Berlin, Germany:
ptsd
stress
traumatization
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases