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Набор скоро начнётся NCT06748261

AI-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary CTA

— Наблюдательное Cardiovascular Diseases Hypertrophic Cardiomyopathy (HCM) Dilated Cardiomyopathy (DCM) Restrictive Cardiomyopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CCTAI model.
Кому может быть актуально
Состояния в реестре: Cardiovascular Diseases, Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Restrictive Cardiomyopathy. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Artificial Intelligence-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary Computer Tomography Angiography

Обзор

The goal of this observational and diagnostic study is to develop and validate an artificial intelligence assisted approach for coronary computer tomography angiography-(CCTA)-based screening and diagnosis of cardiomyopathies in patients with suspected coronary artery diseases. This study aims to develop a computerized CCTA interpretation using artificial intelligence for multi-label classification task to assist cardiomyopathy diagnosis in the clinical workflow.

Подробное описание

Cardiovascular diseases (CVD) are the leading causes of death and disability worldwide. With coronary artery disease accounting for a large proportion of CVD disease burden, coronary computer tomography angiography (CCTA) has become widely used for a comprehensive assessment of the total coronary atherosclerotic burden. In contrast, cardiac magnetic resonance (CMR) remains the gold standard for evaluating and diagnosing cardiomyopathies. However, clinical application of CMR has been hindered by the time and cost of examination and shortage of qualified doctors and staff. Consequently, the value of CCTA in screening and diagnosis in cardiomyopathies warrants further investigation.

The ability of artificial intelligence to learn distinctive features and to recognize characteristic patterns on big data without extensive manual labor makes it highly effective for interpreting CCTA data. Although very few studies investigated the diagnostic value of CCTA for myocardiopathies, which is by far not established or applied in clinical practice by radiologists, automated image analysis has a clear advantage compared to humans by offering objective and uniform solutions. Further, whether a comprehensive, end-to-end, artificial intelligent approach can be used to analyse CCTA for diagnosis multi-classifications of cardiomyopathies remains unknown.

Therefore, this study aims to develop and validate an artificial intelligence assisted approach on CCTA for screening and diagnosis of cardiomyopathies in patients with suspected coronary artery diseases.

Вмешательства

  • Диагностический тест CCTAI model
    Using a derivative sub-cohort, the investigators aim to first develop an CCTA-based AI-assisted (CCTAI) screening model to distinguish patients with cardiac abnormalities from those normal controls. Second, the investigators target at developing a CCTAI diagnostic model with multi-classification output of cardiomyopathy diagnosis. Both models will be tested in internal validation cohort and external validation cohort.

Первичные конечные точки

  • Diagnostic performance [Срок оценки: CCTA examination before surgical or interventional treatments.]

Критерии участия

Cardiomyopathy cohort:

  • Inclusion Criteria:
  • A clinical diagnosis of cardiomyopathies, including hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, cardiac amyloidosis, myocarditis, arrhythmogenic right ventricular cardiomyopathy, and coronary artery disease/ischemic heart disease.
  • At least one CCTA before surgery or implantable device treatment.
  • Exclusion Criteria:
  • No recorded diagnosis of cardiomyopathy or undetermined type of cardiomyopathy.
  • A clinical diagnosis of secondary cardiac abnormalities due to other organic or systemic diseases.
  • Surgery or implantable device treatment before CCTA examination.

Control cohort:

  • Inclusion Criteria: participants with at least one CCTA examination.
  • Exclusion Criteria: clinical diagnosis of cardiovascular diseases (including cardiomyopathy, history of myocardial infarction, history of cardiac surgery, stent implantation, ICD implantation and so on) or secondary cardiac abnormalities due to systemic diseases.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06748261 · ZS-CCTAI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗