Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)

Официальное название

CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study

Обзор

The CODEX-1 study is a multicenter retrospective observational study designed to assess the diagnostic performance of a novel software application for coronary artery disease (CAD) evaluation. The application integrates automated stenosis detection, CT-derived fractional flow reserve (CT-FFR), and plaque quantification, all performed on-site. A total of 1,000 patients who previously underwent coronary computed tomography angiography (CCTA) and diagnostic invasive coronary angiography (ICA) and/or other non-invasive imaging will be included. The study compares the diagnostic outputs of the software to current clinical practice and expert adjudication, focusing on CAD-RADS categorization, prediction of the need for percutaneous coronary intervention (PCI), and reduction in unnecessary ICA procedures.

Подробное описание

Coronary artery disease (CAD) remains a leading cause of morbidity and mortality worldwide. Coronary computed tomography angiography (CCTA) has become a first-line diagnostic tool for patients with suspected CAD, and its utility can be further enhanced through the use of advanced software for automated assessment. The CODEX-1 study is a multicenter, retrospective, observational cohort study aimed at evaluating the diagnostic performance of a novel on-site software application integrating three key features: automated stenosis detection and CAD-RADS categorization, CT-derived fractional flow reserve (CT-FFR), and quantitative plaque analysis.

The study will include 1,000 patients who underwent CCTA for CAD assessment between 2019 and 2024 at four European centers. All participants also have comparator diagnostic data available, such as invasive coronary angiography (ICA), stress MRI, or CCTA analyzed using alternative methods. The software's output will be compared against current clinical practice and expert consensus, with a focus on diagnostic accuracy, inter-reader variability, and the potential to reduce unnecessary ICA procedures.

The study will not involve any patient intervention, and all data analyses will be performed offline using de-identified imaging datasets. The results are expected to provide evidence on the feasibility and accuracy of integrating multiple diagnostic tools into a single application, enabling faster and more consistent CAD diagnosis in clinical practice.

Вмешательства

• Устройство Diagnostic Software Application for CAD Assessment
  A novel on-premises diagnostic software integrating automated coronary stenosis detection, CT-derived fractional flow reserve (CT-FFR), and plaque quantification for evaluation of coronary artery disease (CAD) using coronary computed tomography angiography (CCTA) datasets.

Первичные конечные точки

• Diagnostic accuracy of CAD-RADS classification using the diagnostic software [Срок оценки: At study completion (expected March 2025)]
• Reproducibility of CAD-RADS classification using the diagnostic software [Срок оценки: At study completion (expected March 2025)]

Вторичные конечные точки (3)

• User satisfaction with the diagnostic software application [Срок оценки: After completion of image analysis (expected March 2025)]
• Accuracy of the software in predicting the need for percutaneous coronary intervention (PCI) [Срок оценки: At study completion (expected March 2025)]
• Proportion of invasive coronary angiographies (ICA) without PCI potentially avoidable based on software analysis [Срок оценки: At study completion (expected March 2025)]

Критерии участия

Критерии включения

• Age 18 years or older
• Underwent coronary computed tomography angiography (CCTA) for the diagnosis or assessment of coronary artery disease (CAD) between 2019 and 2024
• Availability of comparator diagnostic data within 1 month before or after the CCTA, such as: Invasive coronary angiography (ICA), Stress MRI, Alternative CCTA analysis software, Documented clinical events

Критерии исключения

\- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 2 центра

• Amsterdam University Medical Center (AUMC) — Amsterdam
• Cardiologie Centra Nederland (CCM) — Amsterdam

Франция · 1 центр

• Université Lyon 1 — Villeurbanne

Испания · 1 центр

• Institute of Biomedical Research of Salamanca — Salamanca

Идентификаторы

NCT: NCT06977295 · CODEX1 TRIAL · PI 2024 09 1728

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗