Software Tested for Reading Past Heart Scans to Detect Narrowed Heart Arteries
Tests software that reads past heart CT scans in adults with heart artery disease.
Key facts
- Who runs it
- Instituto de Investigación Biomédica de Salamanca
- Where
- Amsterdam, NetherlandsSee the 2 sitesAlso in 2 other countries, 2 sites
- Trial code
- Registry title
- Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
- Status
- Recruiting
- People taking part
- 1,000 people, planned
- Started
- 14 Jul 2025
- Expected to end
- 30 Apr 2027
- Type of study
- Observational
- Treatments tested
- Diagnostic Software Application for CAD Assessment
- Record updated
- 21 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a coronary CT scan (CCTA) for coronary artery disease between 2019 and 2024. It tests software that reads these old scans.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Coronary artery disease being diagnosed or assessed with a coronary CT scan.
Main reasons for not taking part
- Scan image quality too poor to judge narrowing of the coronary arteries in routine care
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use
Where in Netherlands
Also in 2 other countries, 2 sites
- Amsterdam University Medical Center (AUMC)Amsterdam, NetherlandsContact: Nils Planken., MD PhDTaking people
- Cardiologie Centra Nederland (CCM)Amsterdam, NetherlandsContact: Michiel Winter, MD PhDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Cohort_1
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: Diagnostic Software Application for CAD Assessment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study
- Plain-language title
- Software Tested for Reading Past Heart Scans to Detect Narrowed Heart ArteriesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 21 April 2026