Early Identification and Diagnosis of BAD-related Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Multisource clinical-imaging artificial intelligence diagnostic assessment
Diagnostic testThe 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.
Treatment groups
1,602 Participants
are divided into 2 treatment groupsGroup A: BAD-related stroke cohort1 intervention
Group B: Non-BAD stroke cohort1 intervention
Trial outcomes
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.
Time frame
Baseline acute phase, after completion of required clinical and neuroimaging assessments, within 7 days after symptom onset or last known wellSecondary 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.
Time frame
At enrollment, using non-imaging clinical data available within 24 hours after admissionOther outcomes
1
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 enrollment2
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 onsetSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
Institute of Automation, Chinese Academy of Sciences
Collaborator
Beijing Zhongke Ruiyi Information Technology Co., Ltd.
Collaborator
Source ClinicalTrials.gov