Atherosclerosis, Coronary Artery Disease, Myocardial Ischemia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDiagnostic 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.
Sponsors
Instituto de Investigación Biomédica de Salamanca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
\- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of CAD-RADS classification using the diagnostic software | At study completion (expected March 2025) | 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 | At study completion (expected March 2025) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User satisfaction with the diagnostic software application | After completion of image analysis (expected March 2025) | 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) | At study completion (expected March 2025) | 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 | At study completion (expected March 2025) | Percentage of ICA procedures not followed by PCI that could have been avoided based on retrospective evaluation with the diagnostic software. |
Countries
France, Netherlands, Spain
Contacts
CONTACTCandelas Pérez Del Villar Moro, PhD MD
PRINCIPAL_INVESTIGATORCandelas Pérez Del Villar Moro, PhD MD
Fundación de Investigación Biomédica de Salamanca (FIBSAL)
Outcome results
None listed