Cognitive Outcomes in BAD-related Stroke

NCT07761182 · tracked via the Priya Life Science China tracker

Sponsor

Peking Union Medical College Hospital

Phase

Observational

Started

2026-09-01

Last updated

2026-08-12

Condition(s) studied

Branch Atheromatous DiseaseCognitiveDeterioration, Clinical

Investigational drug(s) / intervention(s)

END exposure

END exposure: It is not an intervention. It is an exposure. END is defined as an increase in NIHSS total score of ≥4 points or an increase in motor NIHSS score of ≥2 points within 7 days of stroke onset.Deterioration due to intracranial hemorrhage will not be considered as END.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Peking Union Medical College Hospital	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07761182 on ClinicalTrials.gov ↗ ← All trials in China