Cognitive Outcomes in BAD-related Stroke

N/ANot Yet RecruitingNCT07761182

Peking Union Medical College Hospital60 enrolled

Overview

Branch atheromatous disease (BAD) is a distinct subtype of ischemic stroke that is particularly prevalent among Chinese and other Asian populations. Patients with BAD are prone to early neurological deterioration and poor functional outcomes, and BAD is increasingly recognized as an independent disease entity. However, the association between BAD and cognitive impairment remains unclear. This nationwide, multicenter, prospective observational study will prospectively collect epidemiological, clinical, neuroimaging, functional, and cognitive outcome data from patients with BAD. The study aims to investigate the occurrence of cognitive impairment after BAD and identify the clinical and neuroimaging characteristics associated with cognitive impairment. In particular, the relationship between early neurological deterioration (END) and cognitive impairment will be investigated. As an exploratory objective, this study will further explore the potential brain network mechanisms underlying cognitive impairment associated with END events.

Branch atheromatous disease (BAD) is a distinct subtype of ischemic stroke that is particularly prevalent among Chinese and other Asian populations. Patients with BAD are prone to early neurological deterioration (END) and poor functional outcomes. However, the association between BAD and long-term cognitive impairment remains unclear. This nationwide, multicenter, prospective observational study aims to investigate cognitive outcomes after BAD and identify clinical and neuroimaging characteristics associated with cognitive impairment. Patients with BAD will be classified according to END status determined during the acute phase after stroke onset before enrollment. Patients with and without END will then be enrolled in a 1:1 ratio and followed prospectively. The relationship between END status and subsequent cognitive outcomes will be evaluated. As an exploratory objective, this study will investigate potential brain network alterations associated with cognitive impairment after BAD. Epidemiological data, clinical characteristics, TCD, neuroimaging findings, functional outcomes, cognitive outcomes, clinical events, and medication use during follow-up will be collected. Assessments of cognitive and functional outcomes, conducted by trained, independent, blinded evaluators, will be performed at enrollment and 1 year after enrollment. Neuroimaging data will be collected from participating centers, including routine clinical imaging data and advanced neuroimaging data. Advanced neuroimaging assessments will include high-resolution 5T MRI sequences acquired at enrollment and 1 year after enrollment, as well as photon-counting CT imaging, including computed tomography angiography (CTA) and computed tomography perfusion (CTP), performed at enrollment. Imaging acquisition protocols and parameters will be standardized across participating centers to ensure consistency and comparability of imaging data. Baseline is defined as the assessment performed at enrollment. Cognitive assessments performed at enrollment (8-14 days after stroke onset) will serve as the baseline assessment and represent early post-stroke cognitive status. Independent centralized adjudication committees will be established for cognitive assessment and neuroimaging evaluation, with members blinded to the other's findings and all clinical information.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 18-80 years. 2. Time from onset to enrollment: 8-14 days; if onset time is unknown, time from last known normal to enrollment must be 8-14 days. 3. Meet the following imaging inclusion criteria: 3\. 1 DWI infarct: single (isolated) deep (subcortical) infarct 3.2 The culprit vessel is the lenticulostriate artery, and the DWI lesion meets at least one of the following criteria (A/B): A. comma-shaped infarct expanding fan-wise from bottom to top on coronal view; or B. involvement of ≥3 axial slices (slice thickness 5-7 mm) 3.3 No ≥50% stenosis of the ipsilateral middle cerebral artery (confirmed by MRA, CTA, or DSA) 4. Informed consent form signed by the patient or their legally authorized representative. Exclusion Criteria: 1. Baseline imaging showing intracranial hemorrhagic disease, vascular malformation, space-occupying lesion, or other non-ischemic intracranial pathology. 2. Transient ischemic attack or stroke mimics. 3. Cardioembolic causes: including atrial fibrillation, valvular heart disease, infective endocarditis, etc. 4. Tandem extracranial vascular stenosis ≥50% ipsilateral to the infarct lesion. 5. Prior diagnosis of dementia (Alzheimer's disease, frontotemporal dementia, or Lewy body dementia) or significant cognitive decline (IQCODE \> 3.38). 6. Contraindications to photon-counting CT or 5T-MRI. 7. Pregnancy or lactation. 8. Life expectancy \< 1 year.

Outcomes

Primary Outcomes

Mini-Mental State Examination (MMSE) score at 1 year after enrollment

Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). The total MMSE score ranges from 0 to 30 points, with higher scores indicating better global cognitive function. Lower scores indicate greater cognitive impairment after BAD-related stroke.

Time frame: At 1 year after enrollment

Secondary Outcomes

Montreal Cognitive Assessment (MoCA) score

Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a standardized cognitive screening tool designed to evaluate multiple cognitive domains, including visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total MoCA score ranges from 0 to 30 points, with lower scores indicating poorer cognitive function.