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.
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
None
Retrospective cohort of 1,000 adult patients who underwent coronary computed tomography angiography (CCTA) between 2019 and 2024 for the diagnosis or assessment of coronary artery disease (CAD), at four academic hospitals in Spain, the Netherlands, and France. All patients have comparator diagnostic data available, such as invasive coronary angiography (ICA) and/or other non-invasive imaging. No new data collection or interventions will be performed, and all analyses will be conducted offline on de-identified datasets
Cohort
Retrospective
Diagnostic Software Application for CAD Assessment
DeviceA 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.
Diagnostic accuracy of CAD-RADS classification using the diagnostic software
Accuracy of the CAD-RADS category assigned by the software compared to expert adjudication using invasive coronary angiography (ICA) and/or other non-invasive imaging.
Reproducibility of CAD-RADS classification using the diagnostic software
Assessment of inter-reader and intra-reader reproducibility in CAD-RADS classification using the software, evaluated via kappa statistics and intraclass correlation coefficients (ICC), stratified by reader experience.
User satisfaction with the diagnostic software application
User satisfaction will be evaluated using a standardized 5-point Likert scale questionnaire completed by radiologists and cardiac imagers. The scale ranges from 1 (Very dissatisfied) to 5 (Very satisfied). Higher scores indicate greater satisfaction with the usability and performance of the software.
Accuracy of the software in predicting the need for percutaneous coronary intervention (PCI)
Comparison between PCI recommendations generated by the software application (based on CCTA and CT-FFR analysis) and actual PCI decisions made in clinical practice.
Proportion of invasive coronary angiographies (ICA) without PCI potentially avoidable based on software analysis
Percentage of ICA procedures not followed by PCI that could have been avoided based on retrospective evaluation with the diagnostic software.
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