Early Identification and Diagnosis of BAD-related Stroke
SMART-BAD
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
2 other identifiers
observational
1,602
1 country
11
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2026
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2026
CompletedFirst Posted
Study publicly available on registry
July 9, 2026
CompletedStudy Start
First participant enrolled
July 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
July 9, 2026
July 1, 2026
1.5 years
July 5, 2026
July 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
At enrollment, using non-imaging clinical data available within 24 hours after admission
Other Outcomes (2)
Occurrence of early neurological deterioration
Within 7 days after enrollment
Modified Rankin Scale score at 90 days
90 days after stroke onset
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Beijing Fangshan District Liangxiang Hospital
Beijing, China
Beijing Haidian Hospital
Beijing, China
Beijing Huaxin Hospital (The First Hospital of Tsinghua University)
Beijing, China
Beijing Jingmei Group General Hospital
Beijing, China
Beijing Longfu Hospital
Beijing, China
Beijing Puren Hospital
Beijing, China
Beijing Shijingshan Hospital
Beijing, China
Beijing Shijitan Hospital, Capital Medical University
Beijing, China
Beijing Sixth Hospital
Beijing, China
Beijing Yanqing District Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Ni, MD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 90 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2026
First Posted
July 9, 2026
Study Start
July 15, 2026
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
July 9, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
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.