Branch Atheromatous DiseaseSMART-BADNCT07693816
Early Identification and Diagnosis of BAD-related Stroke
An observational study of Branch Atheromatous Disease and Acute Ischemic Stroke, run by Peking Union Medical College Hospital at 11 sites in China.
Trial summary
Branch atheromatous disease (BAD)-related stroke is an important subtype of acute ischemic stroke involving penetrating arteries and is associated with early neurological deterioration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Branch Atheromatous Disease, Acute Ischemic Stroke, Cerebral Infarction
- What is being tested?
- Multisource clinical-imaging artificial intelligence diagnostic assessment
- How many people
- 1,602 participants
- Where
- 11 sitesChina
- Study dates
- 15 Jul 2026to 31 Dec 2028
- How long will I take part?
- 90 Days
- 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: 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.
Who may be able to join
- Age 18 to 80 years.
- Diagnosis of acute ischemic stroke.
- Time from symptom onset to enrollment ≤ 1 week; if the onset time is unknown, time from last known well to enrollment ≤ 1 week.
- Availability of required baseline clinical and neuroimaging assessments according to the study protocol.
- Written informed consent provided by the participant or legally authorized representative.
- Participants will be classified into the BAD-related stroke cohort if they meet all predefined BAD-related stroke diagnostic criteria, including:
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- A single isolated deep subcortical infarct on diffusion-weighted imaging.
- The presumed culprit perforating artery is the lenticulostriate artery or the paramedian pontine artery.
- For lenticulostriate artery territory infarction: a comma-shaped lesion extending from inferior to superior direction on coronal DWI or involvement of ≥3 axial DWI slices with 5-7 mm slice thickness.
- For paramedian pontine artery territory infarction: a lesion extending from the deep pons to the ventral surface of the pons on axial DWI.
- No ≥50% stenosis of the corresponding parent artery, confirmed by MRA, CTA, or DSA.
- Participants with acute ischemic stroke who do not meet BAD-related stroke criteria will be classified into the non-BAD acute ischemic stroke cohort.
Who cannot join
- General exclusion criteria for all participants:
- Intracranial hemorrhage, vascular malformation, aneurysm, brain abscess, malignant intracranial mass, or other non-ischemic intracranial lesion on baseline CT, MRI, MRA, CTA, or DSA.
- Pre-stroke modified Rankin Scale score ≥2.
- Life expectancy ≤6 months.
- Unable to tolerate MRI examination.
- Pregnancy or breastfeeding.
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- Participation in another clinical study within 3 months before informed consent or current participation in another clinical study that may interfere with this study.
- Additional criteria that preclude classification as BAD-related stroke:
- Ipsilateral extracranial tandem artery stenosis ≥50%.
- Definite cardioembolic source, including atrial fibrillation, myocardial infarction, clinically significant valvular heart disease, dilated cardiomyopathy, infective endocarditis, atrioventricular conduction disease, or heart rate <50 beats/min as defined in the protocol.
- Receipt of or planned acute-phase endovascular treatment after stroke onset.
- Stroke due to other determined causes, such as moyamoya disease, arterial dissection, or vasculitis.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Beijing Fangshan District Liangxiang Hospital
Beijing
Qingwei Meng, 86 18500626138, mengqingwei1002@sina.com
- Recruiting
Beijing Haidian Hospital
Beijing
Zhenghong Zhou, 86 18810425636, kongquezzh@126.com
- Recruiting
Beijing Huaxin Hospital (The First Hospital of Tsinghua University)
Beijing
Li Wang, 86 13611066774, WL0050685@sina.com
- Recruiting
Beijing Jingmei Group General Hospital
Beijing
Guixia Fu, 86 13488675566, fuguixia-china@163.com
- Recruiting
Beijing Longfu Hospital
Beijing
Zhiqiang Yang, 86 19520156253, 13651227925@126.com
- Recruiting
Beijing Puren Hospital
Beijing
Kun Wang, 86 13611362026, 493107264@qq.com
- Recruiting
Beijing Shijingshan Hospital
Beijing
Ying Chen, 86 13671189196, cying_217@sina.com
- Recruiting
Beijing Shijitan Hospital, Capital Medical University
Beijing
Junfang Ma, 86 18001385368, treemjf@163.com
- Recruiting
Beijing Sixth Hospital
Beijing
Jingjing Hou, 86 13651219645
- Recruiting
Beijing Yanqing District Hospital
Beijing
Fei Wang, 86 15321208163, 2190063233@qq.com
- Recruiting
Peking Union Medical College Hospital
Beijing
Shengde Li, MD, 86 010-69156371, lishengde.medicine@qq.com
About this study
Official title: Establishment and Validation of a Novel Intelligent Diagnostic Model for BAD-related Stroke Based on the Fusion of Multi-source Clinical Image Information and Its Promotion
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.
Read the detailed description
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.
- Being tested
- Multisource clinical-imaging artificial intelligence diagnostic assessment
- Keywords
- Branch atheromatous disease, Acute ischemic stroke, Artificial intelligence, Machine learning, Deep learning, Diagnostic model, Multimodal imaging, Magnetic resonance imaging, Lenticulostriate artery, Paramedian pontine artery
- Medical subject headings
- Ischemic Stroke, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisource clinical-imaging artificial intelligence diagnostic assessmentDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| BAD-related stroke cohort | Adults with acute ischemic stroke who meet predefined clinical-imaging diagnostic criteria for branch atheromatous disease-related stroke after central adjudication. Receives: Diagnostic Test: Multisource clinical-imaging artificial intelligence diagnostic assessment | |
| Non-BAD stroke cohort | 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. Receives: Diagnostic Test: Multisource clinical-imaging artificial intelligence diagnostic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline acute phase, after completion of required clinical and neuroimaging assessments, within 7 days after symptom onset or last known well
Secondary outcomes (1)
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.
Measured: At enrollment, using non-imaging clinical data available within 24 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Branch Atheromatous DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,602 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Automation, Chinese Academy of Sciences, Beijing Zhongke Ruiyi Information Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jun Ni, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693816
- Sponsor's protocol ID
- BAD SF2026
- Other IDs
- 2026-2-4014
- Acronym
- SMART-BAD
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Validation of a Novel Intelligent Diagnostic Model for BAD-related Stroke Based on the Fusion of Multi-source Clinical Image Information and Its Promotion
- ClinicalTrials.gov ID
- NCT07693816
- Acronym / sponsor ID
- SMART-BAD / BAD SF2026
- Keywords
- Branch atheromatous disease, Acute ischemic stroke, Artificial intelligence, Machine learning, Deep learning, Diagnostic model, Multimodal imaging, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,602 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Institute of Automation, Chinese Academy of Sciences, Beijing Zhongke Ruiyi Information Technology Co., Ltd.
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAD-related stroke cohort | – | Diagnostic Test: Multisource clinical-imaging artificial intelligence diagnostic assessmentAdults with acute ischemic stroke who meet predefined clinical-imaging diagnostic criteria for branch atheromatous disease-related stroke after central adjudication. |
| Non-BAD stroke cohort | – | Diagnostic Test: Multisource clinical-imaging artificial intelligence diagnostic assessmentAdults 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- Age 18 to 80 years.
- Diagnosis of acute ischemic stroke.
- Time from symptom onset to enrollment ≤ 1 week; if the onset time is unknown, time from last known well to enrollment ≤ 1 week.
- Availability of required baseline clinical and neuroimaging assessments according to the study protocol.
- Written informed consent provided by the participant or legally authorized representative.
Key exclusion criteria (12 listed)
- Intracranial hemorrhage, vascular malformation, aneurysm, brain abscess, malignant intracranial mass, or other non-ischemic intracranial lesion on baseline CT, MRI, MRA, CTA, or DSA.
- Pre-stroke modified Rankin Scale score ≥2.
- Life expectancy ≤6 months.
- Unable to tolerate MRI examination.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisource clinical-imaging artificial intelligence diagnostic assessmentThe 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. | Diagnostic test | BAD-related stroke cohort, Non-BAD stroke cohort |
Primary outcome
Overall diagnostic accuracy of the AI-assisted model for identifying BAD-related stroke
Time frame: Baseline acute phase, after completion of required clinical and neuroimaging assessments, within 7 days after symptom onset or last known well
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.
1 secondary outcome
Overall accuracy of the early screening model for identifying possible BAD-related stroke
Time frame: At enrollment, using non-imaging clinical data available within 24 hours after admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Ni, MD principal investigator
Peking Union Medical College Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Branch Atheromatous Disease and Acute Ischemic Stroke, run by Peking Union Medical College Hospital at 11 sites 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 12 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 (010-69156371, lishengde.medicine@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall diagnostic accuracy of the AI-assisted model for identifying BAD-related stroke (time frame: Baseline acute phase, after completion of required clinical and neuroimaging assessments, within 7 days after symptom onset or last known well). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.