AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography

Официальное название

Artificial Intelligence-Based Assessment of Low-Gradient Aortic Stenosis Severity Using Echocardiographic Images

Обзор

The purpose of this study is to evaluate the effectiveness of an artificial intelligence (AI) model developed by the investigators for identifying severe low-gradient aortic valve stenosis. Accurate assessment of stenosis severity is crucial for proper qualification for surgical treatment. It is expected that the use of AI will improve diagnostic accuracy and thereby support better clinical outcomes. Patients with suspected significant low-gradient aortic stenosis will be enrolled. The study is observational and involves no additional risk for participants. Standard imaging studies performed for clinical indications will be additionally analyzed by the AI model, which will classify aortic stenosis as severe or moderate. The model's results will not influence the clinical management of participants but will be compared with physicians' assessments to validate its diagnostic performance. The study will be conducted in 2025-2026. The findings will provide insights into the usefulness of AI in the diagnosis of severe aortic stenosis and may contribute to the development of advanced clinical decision-support tools.

Подробное описание

This study is a prospective multicenter observational validation of an artificial intelligence (AI) model for differentiating severe low-gradient from moderate aortic stenosis using transthoracic echocardiography images. The model, developed and published by the investigators, demonstrated promising diagnostic performance in retrospective data. In the present trial, approximately 300 participants with suspected significant low-gradient aortic stenosis will be enrolled during 2025-2026. Standard imaging studies performed for clinical indications will be analyzed by the AI model, which will classify aortic stenosis as severe or moderate. The AI-derived results will not influence clinical decision-making but will be compared with physicians assessments to evaluate diagnostic accuracy and reproducibility in real-world practice.

Вмешательства

• Диагностический тест AI diagnostic test for severe low-gradient aortic stenosis
  All participants will undergo standard transthoracic echocardiography performed for clinical indications. Echocardiographic images will be analyzed both by experienced physicians and by the investigational AI model. Additional diagnostic tests (such as cardiac CT, low-dose dobutamine stress echocardiography or transesophageal echocardiography) may be performed if clinically indicated, according to current guideline recommendations. The AI-derived results will not influence clinical decision-maki

Первичные конечные точки

• Area Under the Receiver Operating Characteristic Curve (AUC) describing the sensitivity-specificity relationship of the AI model. [Срок оценки: At the time of the nearest Heart Team meeting following the echocardiographic examination (typically within 1 week).]

Вторичные конечные точки (1)

• Diagnostic performance of the AI model in clinically relevant subgroups. [Срок оценки: At the nearest Heart Team meeting following the echocardiographic examination (typically within 1 week).]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Clinical suspicion of significant low-gradient aortic stenosis
• Echocardiographic examination performed for clinical indications
• Ability to provide informed consent

Критерии исключения

• Previous aortic valve intervention (surgical or transcatheter)
• Inadequate image quality precluding echocardiographic analysis
• Concomitant severe valvular disease (severe mitral stenosis or mitral/aortic regurgitation) that could confound assessment
• Patients unwilling or unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Польша · 1 центр

• Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland — Warsaw

Публикации

• Wrzosek M, Buchwald M, Czernik P, Kupinski S, Zatorska K, Jasinska A, Zakrzewski D, Pukacki J, Mazurek C, Pekal R, Hryniewiecki T. Diagnosing Severe Low-Gradient vs Moderate Aortic Stenosis with Artificial Intelligence Based on Echocardiography Images. J Imaging Inform Med. 2026 Feb;39(1):926-932. doi: 10.1007/s10278-025-01497-4. Epub 2025 Apr 21. PMID 40259202

Идентификаторы

NCT: NCT07144189 · 4.35/VI/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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