cerebrovascular accident stroke
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - First-ever ischemic stroke. - MMSE score *15 (to ensure valid testing). - Written informed consent. - Sufficient knowledge of the Dutch language. - Participation of informant.
Exclusion criteria
Exclusion criteria: - Recurrent stroke. - Age younger than 40 years (to exclude atypical strokes). - Pre-stroke dementia (assessed by a semi-structured interview with a relative, based on DSM-IV criteria of dementia). - Psychiatric and neurological disease other than the qualifying event known to affect cognition such as schizophrenia, bipolar disorder, substance abuse, Parkinson*s disease, or epilepsy. - Current episode of depression at admission (as evidenced by medical records and patient or informant interview). In contrast, a lifetime history of depression will not be considered as a reason for exclusion as this is considered a potential risk factor for PSD. - Severe aphasia (as it interferes with understanding and following test instructions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are a) vascular cognitive impairment (this term includes both vascular MCI and post-stroke dementia and is therefore broadly defined as a score * 1.5 standard deviations below the general population mean (based on available norm scores); also, it must represent a significant decline from premorbid levels of functioning (based on informant interview and patient's self-report), and considered a consequence of vascular insufficiency/disease), b) minor or major depression as defined by a diagnostic interview and severity ratings, and c) apathy defined by symptoms frequency severity ratings. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include a) slope analyses of neuropsychological trajectories in the domains of memory, executive functions, attention and information processing speed during the observational period, b) incident post-stroke dementia, c) mortality, d) recurrent stroke events, e) quality of life and f) level of disability. Other study parameters are: comprehensive baseline assessments, which include history of depression, medical history, 3T structural brain MRI, blood samples to determine levels of inflammatory and immunological markers (acute response proteins, cytokines, cell adhesion molecules, antibodies), and DNA (for genetic testing of candidate genotypes). | — |
Countries
Netherlands
Outcome results
None listed