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Идёт набор NCT05509010

AI Driven National Platform for CT cOronary Angiography for clinicaL and industriaL applicatiOns Registry

Наблюдательное CAD Coronary Artery Disease Coronary Stenosis Plaques; Epicardial

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: CTCA.
Кому может быть актуально
Состояния в реестре: CAD, Coronary Artery Disease, Coronary Stenosis, Plaques; Epicardial. Базовые параметры: 21 лет — 80 лет · 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
Сингапур
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

AI Driven National Platform for CT cOronary Angiography for clinicaL and industriaL applicatiOns Registry (APOLLO)

Обзор

The overall aim is to build an AI driven national Platform for CT cOronary angiography for clinicaL and industriaL applicatiOns (APOLLO) for automated anonymization, reporting, Agatston scoring and plaque quantification in CAD. It is a "one-stop" platform spanning diagnosis to clinical management and prognosis, and aid in predicting pharmacotherapy response.

Подробное описание

Coronary artery disease (CAD), a blockage of the blood vessels, affects 6% of the general population and up to 20% of those over 65 years of age. CAD is a leading cause of cardiac mortality in Singapore and worldwide, with 19% of deaths in Singapore due to CAD (MOH website).

Numbers of CAD cases are increasing due to ageing and the higher prevalence of contributary diseases such as diabetes. Computed Tomography Coronary Angiography (CTCA) is the first-line investigation for CAD as indicated by the National Institute for Clinical Excellence (NICE) guidelines. Recent Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) and Scottish Computed Tomography of the Heart (SCOT-HEART) trials support CTCA as the dominant means for evaluating coronary anatomy and physiology as it increases diagnostic certainty, improves efficiency of triage to invasive catheterization and reduces radiation exposure when compared to functional stress testing.

Currently, CAD report generation requires 3-6 hours of a CT specialist's time to annotate scans, with inter-observer variability of 20%. In addition, there is no effective singular toolkit to analyse Agatston scores (a measure of calcified CAD), severity of stenosis, and plaque characterisation.

These problems have severely constrained the effectiveness of CTCA as a diagnostic and research tool. The investigators plan to build upon Singapore's competitive advantages in artificial intelligence (AI) to provide a solution to these gaps.

Вмешательства

  • Процедура CTCA
    CTCA is performed as part of routine care procedure.

Первичные конечные точки

  • AI precision toolkits: AI stenosis reporting [Срок оценки: baseline]
  • AI precision toolkits: Agatston scoring [Срок оценки: baseline]
  • AI precision toolkits: Plaque [Срок оценки: baseline]
  • AI precision toolkits: EAT analysis [Срок оценки: baseline]
Вторичные конечные точки (3)
  • AI outcome analysis [Срок оценки: one to five years from baseline]
  • AI outcome analysis [Срок оценки: one to five years from baseline]
  • AI outcome analysis [Срок оценки: one to five years from baseline]

Критерии участия

Критерии включения

  • Age ≥21 years old
  • Signed informed consent
  • Clinically indicated for evaluation by CTCA

Критерии исключения

  • Individuals unable to provide informed consent
  • Known complex congenital heart disease
  • Planned invasive angiography for reasons other than CAD
  • Non-cardiac illness with life expectancy < 2 years
  • Pregnancy
  • Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
  • Cardiac event and/or coronary revascularization (percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG) and/or valvular repair/replacement prior to CTCA
  • Glomerular Filtration Rate ≤ 30mL/min
  • Known allergy to iodinated contrast agent
  • Contraindications to beta blockers or nitroglycerin or adenosine

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Сингапур · 3 центра
  • National Heart Centre Singapore — Singapore
  • National University Hospital — Singapore
  • Tan Tock Seng Hospital — Singapore

Публикации

  • Leng S, Cheng N, Tan E, Baskaran L, Teo L, Yew MS, Ngiam KY, Huang W, Chai P, Ong CC, Sia CH, Singh M, Loong YT, Raffiee NAS, Wang X, Allen J, Tan SY, Chan M, Lee HK, Zhong L. Deep learning-based quantification of epicardial adipose tissue volume from non-contrast computed tomography images: a multi-centre study. Eur Heart J Digit Health. 2025 Oct 13;6(6):1223-1233. doi: 10.1093/ehjdh/ztaf116. eCo PMID 41267847
  • Baskaran L, Leng S, Dutta U, Teo L, Yew MS, Sia CH, Chew NW, Huang W, Lee HK, Vaughan R, Ngiam KY, Lu Z, Wang X, Tan EWP, Cheng NZY, Tan SY, Chan MY, Zhong L; APOLLO investigators. Cohort profile: AI-driven national Platform for CCTA for clinicaL and industriaL applicatiOns (APOLLO). BMJ Open. 2024 Dec 2;14(12):e089047. doi: 10.1136/bmjopen-2024-089047. PMID 39622571
  • Wang X, Leng S, Lu Z, Huang S, Lee BH, Baskaran L, Yew MS, Teo L, Chan MY, Ngiam KY, Lee HK, Zhong L, Huang W. Context-aware deep network for coronary artery stenosis classification in coronary CT angiography. Annu Int Conf IEEE Eng Med Biol Soc. 2023 Jul;2023:1-4. doi: 10.1109/EMBC40787.2023.10340650. PMID 38083399

Идентификаторы

NCT: NCT05509010 · APOLLO

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗