Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study) (CODEX1)

Instituto de Investigación Biomédica de Salamanca

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis

Treatments: Device: Diagnostic Software Application for CAD Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT06977295

CODEX1 TRIAL

PI 2024 09 1728 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Cohort_1

Description:

Patients who underwent coronary computed tomography angiography (CCTA) between 2019 and 2024 for the assessment or diagnosis of coronary artery disease (CAD), with available comparator diagnostic data such as invasive coronary angiography (ICA) and/or other non-invasive imaging. No interventions are performed as part of this study

Treatment:

Device: Diagnostic Software Application for CAD Assessment