Software that analyzes heart CT scans to detect coronary artery disease
CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study
This project will test a new software that uses past coronary CT scans to see if it can accurately find blockages and predict which patients might need procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Biomédica de Salamanca Academic / other |
| Locations | 4 sites (Villeurbanne and 3 other locations) |
| Trial ID | NCT06977295 on ClinicalTrials.gov |
What this trial studies
CODEX-1 is a multicenter retrospective observational study using de-identified CCTA images from 1,000 patients collected at European centers between 2019 and 2024. The software combines automated stenosis detection and CAD-RADS categorization, CT-derived fractional flow reserve (CT-FFR), and quantitative plaque analysis, and runs entirely on-site. Outputs will be compared to invasive coronary angiography, stress MRI, or alternative CCTA analyses and to expert adjudication to measure diagnostic accuracy and inter-reader variability. All analyses are performed offline and no new tests or interventions are performed on patients.
Who should consider this trial
Good fit: Adults (18+) who had a coronary CT angiogram between 2019 and 2024 and have a comparator diagnostic test (ICA, stress MRI, or alternate CCTA analysis) within one month are ideal candidates for inclusion.
Not a fit: Patients whose CT images are of insufficient quality or who lack nearby comparator diagnostic data would not be included and would not directly benefit from this analysis.
Why it matters
Potential benefit: If successful, the software could provide faster, more consistent noninvasive diagnoses and help reduce unnecessary invasive angiograms.
How similar studies have performed: Prior studies of CT-FFR and automated plaque/stenosis tools have shown promise for improving diagnostic accuracy, but combining all three functions into a single on-site application is relatively novel and needs validation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Villeurbanne and 3 other locations
- Université Lyon 1 — Villeurbanne, France (Recruiting)
- Amsterdam University Medical Center (AUMC) — Amsterdam, Netherlands (Recruiting)
- Cardiologie Centra Nederland (CCM) — Amsterdam, Netherlands (Recruiting)
- Institute of Biomedical Research of Salamanca — Salamanca, Salamanca, Spain (Recruiting)
Study contacts
- Principal investigator: Candelas Pérez Del Villar Moro, PhD MD — Fundación de Investigación Biomédica de Salamanca (FIBSAL)
- Study coordinator: Candelas Pérez Del Villar Moro, PhD MD
- Email: mcperezvi@saludcastillayleon.es
- Phone: +34 923 29 11 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.