An observational study in Branch Atheromatous Disease, Cognitive and Deterioration, Clinical, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Peking Union Medical College Hospital · Observational
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.
47 studies on the registry are indexed under Clinical Deterioration; 15 are open to participants now.
This study's planned enrollment of 60 is below the median of 240 across 25 observational studies indexed under Clinical Deterioration.
Browse Clinical Deterioration studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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. form signed by the patient or their legally authorized representative.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients 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.
Other: END exposure
Patients with branch atheromatous disease (BAD)-related stroke who do not meet the predefined criteria of END.
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.
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
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.
Time frame: At enrollment and 1 year after enrollment
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.
Time frame: At enrollment
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.
Time frame: At enrollment and 1 year after enrollment
Trail Making Test Part B (TMT-B)
Executive function will be assessed using TMT-B. Longer completion time indicates poorer executive function.
Time frame: At enrollment and 1 year after enrollment
Auditory Verbal Learning Test (AVLT) score
Memory function will be assessed using the Auditory Verbal Learning Test (AVLT). Lower scores indicate poorer memory function.
Time frame: At enrollment and 1 year after enrollment
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.
Time frame: At enrollment and 1 year after enrollment
Animal Fluency Test score
Language function will be assessed using the Animal Fluency Test. Lower scores indicate poorer language function.
Time frame: At enrollment and 1 year after enrollment
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.
Time frame: At enrollment and 1 year after enrollment
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.
Time frame: At enrollment and 1 year after enrollment
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.
Time frame: At enrollment and 1 year after enrollment
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
Time frame: At enrollment and 1 year after enrollment
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
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
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 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
Time frame: At enrollment and 1 year after enrollment
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
Time frame: At enrollment and 1 year after enrollment
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
Time frame: At enrollment and 1 year after enrollment
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
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
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 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
Time frame: At enrollment and 1 year after enrollment
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
Time frame: At enrollment and 1 year after enrollment
Ischemic stroke
Ischemic stroke
Time frame: Within 1 year after enrollment
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.
Time frame: Within 1 year after enrollment
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.
Time frame: Within 1 year after enrollment
Myocardial infarction
The occurrence of myocardial infarction during follow-up will be recorded according to the Fourth Universal Definition of Myocardial Infarction (2018).
Time frame: Within 1 year after enrollment
All-cause mortality
All-cause mortality
Time frame: Within 1 year after enrollment
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.
Time frame: Within 1 year after enrollment
Major bleeding
Major bleeding is defined according to PLATO criteria
Time frame: Within 1 year after enrollment
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.
Time frame: At 1 year after enrollment
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
Time frame: At 1 year after enrollment
Middle cerebral artery pulsatility index (PI)
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.
Time frame: At 1 year after enrollment
Middle cerebral artery mean flow velocity (Vm)
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.
Time frame: At 1 year after enrollment
Change from baseline in middle cerebral artery pulsatility index (PI) at 1 year after enrollment
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 mean flow velocity (Vm) at 1 year after enrollment
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
Plan to share: No — For future studies
Start is estimated for Sep 2026; primary completion for Oct 2028, 25 months later.
Of 18 observational studies under Clinical Deterioration, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6. This study's planned 25 months is above that.
Clinical Deterioration covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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