An observational study in Branch Atheromatous Disease, Acute Ischemic Stroke and Cerebral Infarction, sponsored by Peking Union Medical College Hospital. Recruiting at 11 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Peking Union Medical College Hospital · Observational
Branch atheromatous disease (BAD)-related stroke is an important subtype of acute ischemic stroke involving penetrating arteries and is associated with early neurological deterioration. Early recognition and standardized diagnosis remain challenging in routine clinical practice because clinical symptoms are often non-specific and the diagnosis requires integrated clinical and imaging assessment.
This multicenter prospective observational study will collect demographic, clinical, laboratory, electrocardiographic, ultrasound, and multimodal neuroimaging data from adults with acute ischemic stroke within 1 week of symptom onset. Participants will receive routine clinical care determined by their treating physicians; no treatment or management strategy will be assigned by the study protocol. An independent central clinical-imaging adjudication committee will classify participants as BAD-related stroke or non-BAD acute ischemic stroke according to predefined diagnostic criteria. The study aims to develop and externally validate artificial intelligence-assisted screening and diagnostic models for BAD-related stroke and to evaluate their discrimination, calibration, and potential clinical utility.
Branch atheromatous disease (BAD)-related stroke has been increasingly recognized as a clinically meaningful subtype of acute ischemic stroke. It typically presents as a single subcortical infarction in the territory of penetrating arteries, especially the lenticulostriate arteries and paramedian pontine arteries. Because BAD-related stroke is not well captured by conventional etiologic classification systems and because its early diagnosis requires standardized interpretation of clinical and neuroimaging features, delayed or inconsistent recognition may limit subsequent precision-management research.
This study is designed as a multicenter, prospective, observational cohort study. Eligible adults with acute ischemic stroke will be enrolled within 1 week after symptom onset or last known well time. Multisource data will be collected, including demographics, vascular risk factors, baseline neurological assessments, laboratory tests, electrocardiography, carotid/cardiac ultrasound, routine brain MRI, intracranial vascular imaging by MRA/CTA/DSA when available, high-resolution vessel wall MRI when available, ASL perfusion imaging when available, acute-phase treatment information, early neurological deterioration, and 90-day functional outcomes.
The study will include two predefined diagnostic cohorts: participants with BAD-related stroke and participants with non-BAD acute ischemic stroke. BAD-related stroke will be adjudicated by an independent central clinical-imaging committee according to predefined imaging and etiologic criteria. The reference diagnosis will be based on baseline and follow-up clinical information, neuroimaging, vascular imaging, cardiac evaluation, and 90-day follow-up information when applicable.
Artificial intelligence-assisted models will be developed and validated to support early screening and diagnostic classification of BAD-related stroke. The early screening model will use non-imaging or routinely available acute-phase clinical information, whereas the diagnostic model will integrate multisource clinical and imaging information. Model performance will be evaluated in an external validation cohort using discrimination, sensitivity, specificity, accuracy, calibration, and decision curve analysis. The study protocol does not assign any therapeutic intervention, diagnostic procedure beyond routine or protocol-specified observational assessments, or clinical management strategy. All treatments will be determined by the treating physicians according to local practice and applicable guidelines.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 1,602 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke 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.
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The study population will include adults aged 18 to 80 years with acute ischemic stroke who present within 1 week after symptom onset or last known well time at participating stroke centers. Participants will be classified as BAD-related stroke or non-BAD acute ischemic stroke according to predefined diagnostic criteria and independent central clinical-imaging adjudication.
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.
Participants will be classified into the BAD-related stroke cohort if they meet all predefined BAD-related stroke diagnostic criteria, including:
Participants with acute ischemic stroke who do not meet BAD-related stroke criteria will be classified into the non-BAD acute ischemic stroke cohort.
Exclusion Criteria:
General exclusion criteria for all participants:
Additional criteria that preclude classification as BAD-related stroke:
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with acute ischemic stroke who meet predefined clinical-imaging diagnostic criteria for branch atheromatous disease-related stroke after central adjudication.
Diagnostic Test: Multisource clinical-imaging artificial intelligence diagnostic assessment
Adults with acute ischemic stroke who do not meet diagnostic criteria for BAD-related stroke and are included as the comparator cohort for model development and/or external validation.
Diagnostic Test: Multisource clinical-imaging artificial intelligence diagnostic assessment
The diagnostic assessment consists of artificial intelligence-assisted analysis of routinely collected clinical, laboratory, cardiovascular, and multimodal neuroimaging data to estimate the probability of BAD-related stroke. The model output will be compared with an independent central clinical-imaging reference diagnosis. The model will not determine treatment assignment in this observational study.
Overall diagnostic accuracy of the AI-assisted model for identifying BAD-related stroke
Overall diagnostic accuracy will be calculated as the proportion of participants correctly classified as BAD-related stroke or non-BAD acute ischemic stroke by the AI-assisted diagnostic model, using the independent central clinical-imaging adjudication as the reference standard.
Time frame: Baseline acute phase, after completion of required clinical and neuroimaging assessments, within 7 days after symptom onset or last known well
Overall accuracy of the early screening model for identifying possible BAD-related stroke
Overall accuracy will be calculated as the proportion of participants correctly classified as possible BAD-related stroke or non-BAD acute ischemic stroke by the early screening model at a prespecified decision threshold. The model will use only prespecified non-imaging clinical data available at enrollment or within 24 hours after admission. The reference standard will be independent central clinical-imaging adjudication according to predefined diagnostic criteria.
Time frame: At enrollment, using non-imaging clinical data available within 24 hours after admission
Occurrence of early neurological deterioration
Early neurological deterioration was defined as an increase of more than 4 point in NIHSS score or more than 1 point in NIHSS motor score.
Time frame: Within 7 days after enrollment
Modified Rankin Scale score at 90 days
Functional outcome will be assessed using the modified Rankin Scale at 90 days. The distribution of scores and prespecified dichotomized outcomes may be summarized.
Time frame: 90 days after stroke onset
Plan to share: No — Individual participant data will not be shared because the study involves sensitive multicenter clinical and multimodal neuroimaging data from patients with acute ischemic stroke, with residual re-identification risks even after de-identification. Data sharing is restricted by informed consent, ethics approvals, multicenter data-use agreements, institutional policies, and applicable privacy and cybersecurity regulations. Aggregate study results or study-specific questions may be directed to the corresponding author, but participant-level data access is not included in the current IPD sharing plan.
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jan 2028, 18 months later.
Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 18 months is below that.
Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
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