Clinical trial NCT06977295: Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
Official title: CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Atherosclerosis
Myocardial Ischemia
Lead sponsor: Instituto de Investigación Biomédica de Salamanca
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

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

Primary outcomes:
measure: Diagnostic accuracy of CAD-RADS classification using the diagnostic software
timeFrame: At study completion (expected March 2025)
measure: Reproducibility of CAD-RADS classification using the diagnostic software
timeFrame: At study completion (expected March 2025)
Secondary outcomes:
measure: User satisfaction with the diagnostic software application
timeFrame: After completion of image analysis (expected March 2025)
measure: Accuracy of the software in predicting the need for percutaneous coronary intervention (PCI)
timeFrame: At study completion (expected March 2025)
measure: Proportion of invasive coronary angiographies (ICA) without PCI potentially avoidable based on software analysis
timeFrame: At study completion (expected March 2025)
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Université Lyon 1
city: Amsterdam.
country: Netherlands
facility: Amsterdam University Medical Center (AUMC)
city: Amsterdam
country: Netherlands
facility: Cardiologie Centra Nederland (CCM)
city: Salamanca
country: Spain
facility: Institute of Biomedical Research of Salamanca
Study officials:
affiliation: Fundación de Investigación Biomédica de Salamanca (FIBSAL)
name: Candelas Pérez Del Villar Moro, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: