Early Identification and Diagnosis of BAD-related Stroke
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Overall diagnostic accuracy of the AI-assisted model for identifying BAD-related stroke — 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.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Fangshan District Liangxiang Hospital | Beijing | China | Recruiting |
| Beijing Haidian Hospital | Beijing | China | Recruiting |
| Beijing Huaxin Hospital (The First Hospital of Tsinghua University) | Beijing | China | Recruiting |
| Beijing Jingmei Group General Hospital | Beijing | China | Recruiting |
| Beijing Longfu Hospital | Beijing | China | Recruiting |
| Beijing Puren Hospital | Beijing | China | Recruiting |
| Beijing Shijingshan Hospital | Beijing | China | Recruiting |
| Beijing Shijitan Hospital, Capital Medical University | Beijing | China | Recruiting |
| Beijing Sixth Hospital | Beijing | China | Recruiting |
| Beijing Yanqing District Hospital | Beijing | China | Recruiting |
| Peking Union Medical College Hospital | Beijing | China | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07693816 on ClinicalTrials.gov ↗ ← All trials in China