Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
Recruiting now
Conditions studied: Coronary Artery Disease, Atherosclerosis, Myocardial Ischemia
In brief
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.
Key facts
- Study ID
- NCT06977295
- Run by
- Instituto de Investigación Biomédica de Salamanca
- People needed
- 1000
- Starts
- 2025-07-14
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-04-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use
Where it is running
- Université Lyon 1 — Villeurbanne, France (enrolling)
- Amsterdam University Medical Center (AUMC) — Amsterdam, Netherlands (enrolling)
- Cardiologie Centra Nederland (CCM) — Amsterdam, Netherlands (enrolling)
- Institute of Biomedical Research of Salamanca — Salamanca, Salamanca, Spain (enrolling)
Full record on ClinicalTrials.gov
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