Software that analyzes heart CT scans to detect coronary artery disease
Official title: CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study
Run by Instituto de Investigación Biomédica de Salamanca · NCT06977295 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Instituto de Investigación Biomédica de Salamanca Academic / other |
| Locations | 4 sites (Villeurbanne and 3 other locations) |
| Status | Recruiting |
| Started | July 14, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | April 30, 2027 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT06977295 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.