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Early Identification and Diagnosis of BAD-related Stroke (SMART-BAD)

5. července 2026 aktualizováno: Peking Union Medical College Hospital

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

1602

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
      • Beijing, Čína
        • Nábor
        • Peking Union Medical College Hospital
        • Kontakt:
      • Beijing, Čína
        • Nábor
        • Beijing Shijitan Hospital, Capital Medical University
        • Kontakt:
      • Beijing, Čína
        • Nábor
        • Beijing Haidian Hospital
        • Kontakt:
      • Beijing, Čína
        • Nábor
        • Beijing Shijingshan Hospital
        • Kontakt:
      • Beijing, Čína
        • Nábor
        • Beijing Fangshan District Liangxiang Hospital
        • Kontakt:
      • Beijing, Čína
        • Nábor
        • Beijing Huaxin Hospital (The First Hospital of Tsinghua University)
        • Kontakt:
      • Beijing, Čína
        • Nábor
        • Beijing Jingmei Group General Hospital
        • Kontakt:
      • Beijing, Čína
        • Nábor
        • Beijing Longfu Hospital
        • Kontakt:
      • Beijing, Čína
        • Nábor
        • Beijing Puren Hospital
        • Kontakt:
      • Beijing, Čína
        • Nábor
        • Beijing Sixth Hospital
        • Kontakt:
          • Jingjing Hou
          • Telefonní číslo: 86 13651219645
      • Beijing, Čína
        • Nábor
        • Beijing Yanqing District Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Diagnostický test: 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.
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.
Diagnostický test: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall diagnostic accuracy of the AI-assisted model for identifying BAD-related stroke
Časové okno: 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.
Baseline acute phase, after completion of required clinical and neuroimaging assessments, within 7 days after symptom onset or last known well

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall accuracy of the early screening model for identifying possible BAD-related stroke
Časové okno: At enrollment, using non-imaging clinical data available within 24 hours after admission
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.
At enrollment, using non-imaging clinical data available within 24 hours after admission

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Occurrence of early neurological deterioration
Časové okno: Within 7 days after enrollment
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.
Within 7 days after enrollment
Modified Rankin Scale score at 90 days
Časové okno: 90 days after stroke onset
Functional outcome will be assessed using the modified Rankin Scale at 90 days. The distribution of scores and prespecified dichotomized outcomes may be summarized.
90 days after stroke onset

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Peking Union Medical College Hospital

Spolupracovníci

Institute of Automation, Chinese Academy of Sciences
Beijing Zhongke Ruiyi Information Technology Co., Ltd.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jun Ni, MD, Peking Union Medical College Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. července 2026

Primární dokončení (Odhadovaný)

31. ledna 2028

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

5. července 2026

První předloženo, které splnilo kritéria kontroly kvality

5. července 2026

První zveřejněno (Aktuální)

9. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • BAD SF2026
  • 2026-2-4014 (Jiné číslo grantu/financování: Capital's Funds for Health Improvement and Research)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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