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NCT Number: NCT07761182

Cognitive Outcomes in BAD-related Stroke

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.

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Key information

Conditions

Branch Atheromatous Disease Clinical Deterioration Cognitive Deterioration, Clinical Disease Attributes Disease Progression Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-80 years.
  • 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.
  • Meet the following imaging inclusion criteria:
  • 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

  • Baseline imaging showing intracranial hemorrhagic disease, vascular malformation, space-occupying lesion, or other non-ischemic intracranial pathology.
  • Transient ischemic attack or stroke mimics.
  • Cardioembolic causes: including atrial fibrillation, valvular heart disease, infective endocarditis, etc.
  • Tandem extracranial vascular stenosis ≥50% ipsilateral to the infarct lesion.
  • Prior diagnosis of dementia (Alzheimer's disease, frontotemporal dementia, or Lewy body dementia) or significant cognitive decline (IQCODE > 3.38).
  • Contraindications to photon-counting CT or 5T-MRI.
  • Pregnancy or lactation.
  • Life expectancy < 1 year.

Treatment and study plan

END exposure

Other

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Montreal Cognitive Assessment (MoCA) score

    Time frame: At enrollment and 1 year after enrollment

    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.

  2. Mini-Mental State Examination (MMSE) score

    Time frame: At enrollment

    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.

  3. Trail Making Test Part A

    Time frame: At enrollment and 1 year after enrollment

    Attention and executive function will be assessed using the Trail Making Test Part A (TMT-A). Longer completion time indicates poorer cognitive performance.

  4. Trail Making Test Part B (TMT-B)

    Time frame: At enrollment and 1 year after enrollment

    Executive function will be assessed using TMT-B. Longer completion time indicates poorer executive function.

  5. Auditory Verbal Learning Test (AVLT) score

    Time frame: At enrollment and 1 year after enrollment

    Memory function will be assessed using the Auditory Verbal Learning Test (AVLT). Lower scores indicate poorer memory function.

  6. Digit Span Test score

    Time frame: At enrollment and 1 year after enrollment

    Attention and working memory function will be assessed using the Digit Span Test. Lower scores indicate poorer attention and working memory function.

  7. Animal Fluency Test score

    Time frame: At enrollment and 1 year after enrollment

    Language function will be assessed using the Animal Fluency Test. Lower scores indicate poorer language function.

  8. Modified Rey-Osterrieth Figure Copy Test score

    Time frame: At enrollment and 1 year after enrollment

    Visuospatial function will be assessed using the Modified Rey-Osterrieth Figure Copy Test. Lower scores indicate poorer visuospatial function.

  9. Simple Reaction Time Task score

    Time frame: At enrollment and 1 year after enrollment

    Perceptual processing and reaction speed will be assessed using the Simple Reaction Time Task. Longer reaction times indicate poorer perceptual processing and reaction speed.

  10. Facial Emotion Recognition Test score

    Time frame: At enrollment and 1 year after enrollment

    Emotional and social cognition function will be assessed using the Facial Emotion Recognition Test, an authorized assessment tool. Lower scores indicate poorer emotional and social cognition function.

  11. Change from baseline in Mini-Mental State Examination (MMSE) score at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in Mini-Mental State Examination (MMSE) score at 1 year after enrollment

  12. Change from baseline in Montreal Cognitive Assessment (MoCA) score at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in Montreal Cognitive Assessment (MoCA) score at 1 year after enrollment

  13. Change from baseline in Trail Making Test Part A (TMT-A) completion time at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in Trail Making Test Part A (TMT-A) completion time at 1 year after enrollment

  14. Change from baseline in Trail Making Test Part B (TMT-B) completion time at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in Trail Making Test Part B (TMT-B) completion time at 1 year after enrollment

  15. Change from baseline in Auditory Verbal Learning Test (AVLT) score at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in Auditory Verbal Learning Test (AVLT) score at 1 year after enrollment

  16. Change from baseline in Digit Span Test score at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in Digit Span Test score at 1 year after enrollment

  17. Change from baseline in Animal Fluency Test score at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in Animal Fluency Test score at 1 year after enrollment

  18. Change from baseline in Modified Rey-Osterrieth Figure Copy Test score at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in Modified Rey-Osterrieth Figure Copy Test score at 1 year after enrollment

  19. Change from baseline in Simple Reaction Time Task reaction time at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in Simple Reaction Time Task reaction time at 1 year after enrollment

  20. Change from baseline in Facial Emotion Recognition Test score at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in Facial Emotion Recognition Test score at 1 year after enrollment

  21. Ischemic stroke

    Time frame: Within 1 year after enrollment

    Ischemic stroke

  22. Intracerebral hemorrhage

    Time frame: Within 1 year after enrollment

    The occurrence of intracerebral hemorrhage during follow-up will be recorded. Intracerebral hemorrhage is defined as bleeding within the brain parenchyma and does not include subarachnoid hemorrhage, subdural hemorrhage, or epidural hemorrhage.

  23. Stroke

    Time frame: Within 1 year after enrollment

    Stroke is defined as an acute cerebrovascular event caused by either cerebral ischemia or intracranial hemorrhage, including ischemic stroke and hemorrhagic stroke. Hemorrhagic stroke includes intracerebral hemorrhage and subarachnoid hemorrhage.

  24. Myocardial infarction

    Time frame: Within 1 year after enrollment

    The occurrence of myocardial infarction during follow-up will be recorded according to the Fourth Universal Definition of Myocardial Infarction (2018).

  25. All-cause mortality

    Time frame: Within 1 year after enrollment

    All-cause mortality

  26. Bleeding events

    Time frame: Within 1 year after enrollment

    The occurrence of bleeding events during follow-up will be recorded. Bleeding events include any intracranial or extracranial bleeding events occurring after enrollment.

  27. Major bleeding

    Time frame: Within 1 year after enrollment

    Major bleeding is defined according to PLATO criteria

  28. Modified Rankin Scale (mRS) score

    Time frame: At 1 year after enrollment

    Functional outcome will be assessed using the Modified Rankin Scale (mRS). The mRS is a commonly used scale for evaluating the degree of disability and dependence after stroke. The mRS score ranges from 0 to 6 (death), with higher scores indicating greater disability.

  29. Barthel Index (BI) score

    Time frame: At 1 year after enrollment

    Activities of daily living will be assessed using the Barthel Index (BI). The BI score is used to evaluate functional independence in daily activities. The total BI score ranges from 0 to 100 points, with higher scores indicating better functional ability

Other outcomes

  1. Middle cerebral artery pulsatility index (PI)

    Time frame: At 1 year after enrollment

    Pulsatility index (PI) of the middle cerebral artery will be measured by transcranial Doppler ultrasonography (TCD). Higher PI values indicate increased cerebrovascular resistance and are associated with impaired cerebral perfusion.

  2. Middle cerebral artery mean flow velocity (Vm)

    Time frame: At 1 year after enrollment

    Mean flow velocity (Vm) of the middle cerebral artery will be measured by transcranial Doppler ultrasonography (TCD). Vm reflects cerebral blood flow velocity. Lower Vm values may indicate reduced cerebral perfusion and impaired cerebral circulation.

  3. Change from baseline in middle cerebral artery pulsatility index (PI) at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in middle cerebral artery pulsatility index (PI) at 1 year after enrollment

  4. Change from baseline in middle cerebral artery mean flow velocity (Vm) at 1 year after enrollment

    Time frame: At enrollment and 1 year after enrollment

    Change from baseline in middle cerebral artery mean flow velocity (Vm) at 1 year after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Shengde Li, MD

CONTACT

[email protected]

861069156371

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Cognitive Outcomes in Patients With Branch Atheromatous Disease-Related Stroke: A Prospective Cohort Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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