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Branch Atheromatous DiseaseNCT07761182

Cognitive Outcomes in BAD-related Stroke

An observational study of Branch Atheromatous Disease and Cognitive, run by Peking Union Medical College Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
END exposure
How many people
60 participants
Where
1 siteChina
Study dates
1 Sep 2026to 1 Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This is an observational study. The study population will include adults aged 18 to 80 years with BAD-related stroke who are enrolled within 8 to 14 days after stroke onset. END status is determined before enrollment based on clinical deterioration occurring within 7 days after stroke onset, according to predefined criteria. Patients with and without END will be enrolled in 1:1 ratio.

Who may be able to join

  • 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:
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Shengde Li, MD, 86 10 69156371, lishengde.medicine@qq.com

Other trials in China

About this study

Official title: Cognitive Outcomes in Patients With Branch Atheromatous Disease-Related Stroke: A Prospective Cohort 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 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.

Read the detailed description

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.

Being tested
END exposure
Medical subject headings
Clinical Deterioration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • END exposureOther

    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 groups in NCT07761182
Study groupRoleWhat they receive
END groupPatients with branch atheromatous disease (BAD)-related stroke who develop early neurological deterioration (END) within 7 days after stroke onset. END is defined as an increase in NIHSS total score of ≥4 points or an increase in motor NIHSS score of ≥2 points.The baseline NIHSS score for END assessment is defined as the first NIHSS evaluation performed and documented by a clinician after stroke onset. END will be assessed within 7 days after stroke onset. Deterioration due to intracranial hemorrhage will not be considered as END.
Receives: Other: END exposure
Non-END groupPatients with branch atheromatous disease (BAD)-related stroke who do not meet the predefined criteria of END.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 1 year after enrollment

Secondary outcomes (29)
  1. 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.

    Measured: At enrollment and 1 year after enrollment

  2. Mini-Mental State Examination (MMSE) score

    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.

    Measured: At enrollment

  3. Trail Making Test Part A

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

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

  5. Auditory Verbal Learning Test (AVLT) score

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

    Measured: At enrollment and 1 year after enrollment

  6. Digit Span Test score

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

    Measured: At enrollment and 1 year after enrollment

  7. Animal Fluency Test score

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

    Measured: At enrollment and 1 year after enrollment

  8. Modified Rey-Osterrieth Figure Copy Test score

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

    Measured: At enrollment and 1 year after enrollment

  9. Simple Reaction Time Task score

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

    Measured: At enrollment and 1 year after enrollment

  10. Facial Emotion Recognition Test score

    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.

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

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

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

    Measured: At enrollment and 1 year after enrollment

  21. Ischemic stroke

    Ischemic stroke

    Measured: Within 1 year after enrollment

  22. Intracerebral hemorrhage

    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.

    Measured: Within 1 year after enrollment

  23. Stroke

    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.

    Measured: Within 1 year after enrollment

  24. Myocardial infarction

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

    Measured: Within 1 year after enrollment

  25. All-cause mortality

    All-cause mortality

    Measured: Within 1 year after enrollment

  26. Bleeding events

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

    Measured: Within 1 year after enrollment

  27. Major bleeding

    Major bleeding is defined according to PLATO criteria

    Measured: Within 1 year after enrollment

  28. Modified Rankin Scale (mRS) score

    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.

    Measured: At 1 year after enrollment

  29. Barthel Index (BI) score

    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

    Measured: At 1 year after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Oct 2028 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07761182
Sponsor's protocol ID
BADCOG
Status last verified
Jul 2026
First submitted
7 Aug 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: For future studies

Publications

  • Li S, Wang L, Liu B, Zhang P, Zhang J, Chen G, Yang Q, Bian H, Li X, Wu J, Zhao F, Liu S, Bai H, Zhao W, Yue W, Feng K, Tang Y, Lu Z, Li Y, Zhang J, Zhou L, Zhu Y, Ni J, Peng B; BAD-Study Investigators. Clinical and Prognostic Characteristics of Acute BAD-Related Stroke: A Multicenter MRI-Based Prospective Study. Stroke. 2024 Oct;55(10):2431-2438. doi: 10.1161/STROKEAHA.124.047688. Epub 2024 Sep 24.

    PubMed 39315825
  • El Husseini N, Katzan IL, Rost NS, Blake ML, Byun E, Pendlebury ST, Aparicio HJ, Marquine MJ, Gottesman RF, Smith EE; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Council on Lifestyle and Cardiometabolic Health. Cognitive Impairment After Ischemic and Hemorrhagic Stroke: A Scientific Statement From the American Heart Association/American Stroke Association. Stroke. 2023 Jun;54(6):e272-e291. doi: 10.1161/STR.0000000000000430. Epub 2023 May 1.

    PubMed 37125534
  • Yang T, Deng Q, Jiang S, Yan YY, Yuan Y, Wu SM, Zhang ST, Sun JY, Wu B. Cognitive impairment in two subtypes of a single subcortical infarction. Chin Med J (Engl). 2021 Dec 8;134(24):2992-2998. doi: 10.1097/CM9.0000000000001938.

    PubMed 34908257

Questions about this trial

What is this clinical trial studying?

An observational study of Branch Atheromatous Disease and Cognitive, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shengde Li, MD (861069156371, lishengde.medicine@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mini-Mental State Examination (MMSE) score at 1 year after enrollment (time frame: At 1 year after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07761182, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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