Early Identification of BAD-related Stroke in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study collects demographic, clinical, laboratory, ECG, ultrasound, and multimodal neuroimaging data from adults with acute ischemic stroke within one week of symptom onset. An independent central committee will classify participants as BAD-related stroke or non-BAD stroke using predefined criteria, while treatment remains as determined by clinicians. The project uses an artificial intelligence diagnostic assessment that integrates multisource data to help distinguish BAD-related stroke from other AIS subtypes. Enrollment includes two cohorts—BAD-related stroke and non-BAD AIS—with outcomes assessed at 90 days. Data will come from multiple Beijing-area centers, with collaboration from AI and information technology partners.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

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.
* 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.

Where it's running

• 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

Study contacts

• Principal investigator: Jun Ni, MD — Peking Union Medical College Hospital
• Study coordinator: Shengde Li, MD
• Email: lishengde.medicine@qq.com
• Phone: 010-69156371

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.