Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650436
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-13
Brief Title:
DEliriuM in STroke the Link Between Stroke Delirium and Long-term Cognitive Impairment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
DEliriuM in STroke the Link Between Stroke Delirium and Long-term Cognitive Impairment
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DE-MIST
Brief Summary:
Primary objective of this study
determine whether PSD is a risk factor for PSCI independent of brain frailty and premorbid cognitive functioning
Secondary objectives
1 to investigate the role of infarct location imaging markers of brain frailty and brain network disintegration in the development of PSD
2 to investigate the role of persistent brain network disintegration in the development of PSCI
determine whether PSD is a risk factor for PSCI independent of brain frailty and premorbid cognitive functioning
Secondary objectives
1 to investigate the role of infarct location imaging markers of brain frailty and brain network disintegration in the development of PSD
2 to investigate the role of persistent brain network disintegration in the development of PSCI
Detailed Description:
1 Patient characteristics such as age premorbid modified Rankin Scale mRS and stroke characteristics such as stroke severity NIHSS will be documented There will be screened for preexisting cognitive decline by using a Dutch shortened and validated version of the Informant Questionnaire on Cognitive Decline in the Elderly IQCODE Clinical assessments such as NIHSS and mRS will be repeated after 3 and 12 months as part of regular care Comorbid conditions will be documented during the whole duration of the study
2 Previous or concomitant use of drugs will be registered in particular those known to affect cognitive function such as anticholinergic drugs analgo-sedatives or benzodiazepines
3 Delirium assessment during hospitalization delirium assessment will be performed twice a day at the beginning and ending of each day shift with a minimal interval of 5 hours between the two evaluations each day during the first 72 hours after ischemic stroke onset The length of the screening period is based on the results of a prospective observational study that showed that almost all of PSD cases occurred within 72 hours 98 If a patient develops delirium during the first 72 hours after stroke onset delirium monitoring will be continued until 4 negative screening tests are obtained because of possible fluctuations of delirium signs or until the end of the hospitalization Delirium assessments will be performed by a trained nurse using the 4 As Test 4AT and the Richmond Agitation and Sedation Scale RASS The RASS will be used to determine the type of delirium with negative RASS scores indicating hypoactive delirium and a positive RASS score indicating hyperactive delirium
4 EEG recordings will be performed by a trained neurophysiology nurse using 21 electrodes placed according to the 10-20 system with 10 minutes eyes open and 10 minutes eyes closed within one hour of the clinical evaluation during the hospitalization The first EEG will be routinely recorded during the first 24 hours after stroke onset A second EEG will be only be recorded in patients who develop PSD between 24 and 72 hours after stroke onset EEGs recorded during hospitalization are considered standard of care EEG recording will be repeated at 12 months
5 MRI of the brain will be performed during hospitalization standard of care and 12 months after stroke onset Standard acute stroke imaging will involve a 3-T MR scanner with sagittal 3DFLAIR fluid-attenuated inversion recovery sequence T2 sequence fossa posterior with a slice thickness of 2mm axial diffusion sequence slice thickness 4mm 3D-SWI susceptibility weighted imaging sequence slice thickness 2mm and 3D-QALAS sequence Manual segmentation of the acute ischemic lesion will be performed on MRI scans of the brain performed during hospitalization for IS Patients without visible acute ischemic lesions on MRI will be excluded Acute ischemic stroke lesions AIL are defined by the presence of a hyperintense MRI diffusion-weighted imaging DWI lesion with corresponding hypointensity in apparent diffusion coefficient map ADC The DWI and ADC images may also help to discriminate between new ischemic lesions and pre-existent white matter hyperintensities Prior to performing the segmentations for the current study the reviewer will delineate AIL on 10 scans twice with an interval of 1 month with the aim to optimize intraobserver agreement Visual rating of white matter hyperintensities Fazekas scale and cerebral atrophy global cortical atrophy GCA scale as markers of brain frailty
6 Cognitive and mood assessment neuropsychological assessment will take place at 3 months and 12 months after the IS A trained nurse will administer the Montreal Cognitive Assessment MOCA Dutch or French version at these time intervals She will be blinded for the initial occurrence of delirium Depression screening will be performed at the same time intervals by using the Patient Health Questionnaire-2 and the Hospital Anxiety and Depression Scale HADS in order to be able to compare with previously performed delirium studies
2 Previous or concomitant use of drugs will be registered in particular those known to affect cognitive function such as anticholinergic drugs analgo-sedatives or benzodiazepines
3 Delirium assessment during hospitalization delirium assessment will be performed twice a day at the beginning and ending of each day shift with a minimal interval of 5 hours between the two evaluations each day during the first 72 hours after ischemic stroke onset The length of the screening period is based on the results of a prospective observational study that showed that almost all of PSD cases occurred within 72 hours 98 If a patient develops delirium during the first 72 hours after stroke onset delirium monitoring will be continued until 4 negative screening tests are obtained because of possible fluctuations of delirium signs or until the end of the hospitalization Delirium assessments will be performed by a trained nurse using the 4 As Test 4AT and the Richmond Agitation and Sedation Scale RASS The RASS will be used to determine the type of delirium with negative RASS scores indicating hypoactive delirium and a positive RASS score indicating hyperactive delirium
4 EEG recordings will be performed by a trained neurophysiology nurse using 21 electrodes placed according to the 10-20 system with 10 minutes eyes open and 10 minutes eyes closed within one hour of the clinical evaluation during the hospitalization The first EEG will be routinely recorded during the first 24 hours after stroke onset A second EEG will be only be recorded in patients who develop PSD between 24 and 72 hours after stroke onset EEGs recorded during hospitalization are considered standard of care EEG recording will be repeated at 12 months
5 MRI of the brain will be performed during hospitalization standard of care and 12 months after stroke onset Standard acute stroke imaging will involve a 3-T MR scanner with sagittal 3DFLAIR fluid-attenuated inversion recovery sequence T2 sequence fossa posterior with a slice thickness of 2mm axial diffusion sequence slice thickness 4mm 3D-SWI susceptibility weighted imaging sequence slice thickness 2mm and 3D-QALAS sequence Manual segmentation of the acute ischemic lesion will be performed on MRI scans of the brain performed during hospitalization for IS Patients without visible acute ischemic lesions on MRI will be excluded Acute ischemic stroke lesions AIL are defined by the presence of a hyperintense MRI diffusion-weighted imaging DWI lesion with corresponding hypointensity in apparent diffusion coefficient map ADC The DWI and ADC images may also help to discriminate between new ischemic lesions and pre-existent white matter hyperintensities Prior to performing the segmentations for the current study the reviewer will delineate AIL on 10 scans twice with an interval of 1 month with the aim to optimize intraobserver agreement Visual rating of white matter hyperintensities Fazekas scale and cerebral atrophy global cortical atrophy GCA scale as markers of brain frailty
6 Cognitive and mood assessment neuropsychological assessment will take place at 3 months and 12 months after the IS A trained nurse will administer the Montreal Cognitive Assessment MOCA Dutch or French version at these time intervals She will be blinded for the initial occurrence of delirium Depression screening will be performed at the same time intervals by using the Patient Health Questionnaire-2 and the Hospital Anxiety and Depression Scale HADS in order to be able to compare with previously performed delirium studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None