Stroke complicAtions After TraUmatic expeRieNces and Stress

NCT ID: NCT03496480

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 636 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2019-07-01

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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Questionnaires

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

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johanna Schöner

OTHER

Sponsor Role: lead

Responsible Party

Johanna Schöner

study doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Charité Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

EA2/113/16

Identifier Type: -

Identifier Source: org_study_id