Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic Software Application for CAD Assessment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Atherosclerosis, Myocardial Ischemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Netherlands, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study
Overview
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
- Device 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.
Primary outcome measures
- Diagnostic accuracy of CAD-RADS classification using the diagnostic software [Time frame: At study completion (expected March 2025)]
- Reproducibility of CAD-RADS classification using the diagnostic software [Time frame: At study completion (expected March 2025)]
Secondary outcome measures (3)
- User satisfaction with the diagnostic software application [Time frame: After completion of image analysis (expected March 2025)]
- Accuracy of the software in predicting the need for percutaneous coronary intervention (PCI) [Time frame: At study completion (expected March 2025)]
- Proportion of invasive coronary angiographies (ICA) without PCI potentially avoidable based on software analysis [Time frame: At study completion (expected March 2025)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 2 centers
- Amsterdam University Medical Center (AUMC) — Amsterdam
- Cardiologie Centra Nederland (CCM) — Amsterdam
France · 1 center
- Université Lyon 1 — Villeurbanne
Spain · 1 center
- Institute of Biomedical Research of Salamanca — Salamanca
Identifiers
NCT: NCT06977295 · CODEX1 TRIAL · PI 2024 09 1728