Coronary Artery DiseaseCODEX1NCT06977295
Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
An observational study of Coronary Artery Disease and Atherosclerosis, run by Instituto de Investigación Biomédica de Salamanca at 4 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Myocardial Ischemia
- What is being tested?
- Diagnostic Software Application for CAD Assessment
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 14 Jul 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective cohort of 1,000 adult patients who underwent coronary computed tomography angiography (CCTA) between 2019 and 2024 for the diagnosis or assessment of coronary artery disease (CAD), at four academic hospitals in Spain, the Netherlands, and France. All patients have comparator diagnostic data available, such as invasive coronary angiography (ICA) and/or other non-invasive imaging. No new data collection or interventions will be performed, and all analyses will be conducted offline on de-identified datasets
Who may be able to join
- 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 join
- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Candelas Pérez Del Villar Moro, PhD MD contact
4 sites in 3 countries
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam University Medical Center (AUMC)
Amsterdam
Nils Planken., MD PhD
- Recruiting
Cardiologie Centra Nederland (CCM)
Amsterdam
Michiel Winter, MD PhD
France1 site, 1 recruiting
- Recruiting
Université Lyon 1
Villeurbanne
Philippe Douek., MD PhD
Spain1 site, 1 recruiting
- Recruiting
Institute of Biomedical Research of Salamanca
Salamanca, Salamanca, 37007
Candelas Pérez Del Villar Moro, PhD MD, +34 923 29 11 00 ext. 55789, mcperezvi@saludcastillayleon.es
About this study
Official title: CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study
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.
Read the detailed 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.
- Being tested
- Diagnostic Software Application for CAD Assessment
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Software Application for CAD AssessmentDevice
A novel on-premises diagnostic software integrating automated coronary stenosis detection, CT-derived fractional flow reserve (CT-FFR), and plaque quantification for evaluation of coronary artery disease (CAD) using coronary computed tomography angiography (CCTA) datasets.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Diagnostic Software Application for CAD Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CAD-RADS classification using the diagnostic software
Accuracy of the CAD-RADS category assigned by the software compared to expert adjudication using invasive coronary angiography (ICA) and/or other non-invasive imaging.
Measured: At study completion (expected March 2025)
Reproducibility of CAD-RADS classification using the diagnostic software
Assessment of inter-reader and intra-reader reproducibility in CAD-RADS classification using the software, evaluated via kappa statistics and intraclass correlation coefficients (ICC), stratified by reader experience.
Measured: At study completion (expected March 2025)
Secondary outcomes (3)
User satisfaction with the diagnostic software application
User satisfaction will be evaluated using a standardized 5-point Likert scale questionnaire completed by radiologists and cardiac imagers. The scale ranges from 1 (Very dissatisfied) to 5 (Very satisfied). Higher scores indicate greater satisfaction with the usability and performance of the software.
Measured: After completion of image analysis (expected March 2025)
Accuracy of the software in predicting the need for percutaneous coronary intervention (PCI)
Comparison between PCI recommendations generated by the software application (based on CCTA and CT-FFR analysis) and actual PCI decisions made in clinical practice.
Measured: At study completion (expected March 2025)
Proportion of invasive coronary angiographies (ICA) without PCI potentially avoidable based on software analysis
Percentage of ICA procedures not followed by PCI that could have been avoided based on retrospective evaluation with the diagnostic software.
Measured: At study completion (expected March 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start14 Jul 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Biomédica de Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Candelas Pérez Del Villar Moro, PhD MD, Principal investigator, Fundación de Investigación Biomédica de Salamanca (FIBSAL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977295
- Sponsor's protocol ID
- CODEX1 TRIAL
- Other IDs
- PI 2024 09 1728
- Acronym
- CODEX1
- Status last verified
- Apr 2026
- First submitted
- 9 May 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including imaging datasets and related diagnostic parameters, may be shared for additional analyses in compliance with GDPR and FAIR data principles. Data will be stored in secure, GDPR-compliant repositories and may be made available upon reasonable request following project completion and publication of main results.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study
- ClinicalTrials.gov ID
- NCT06977295
- Acronym / sponsor ID
- CODEX1 / CODEX1 TRIAL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Instituto de Investigación Biomédica de SalamancaUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort_1 | – | Device: Diagnostic Software Application for CAD AssessmentPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective cohort of 1,000 adult patients who underwent coronary computed tomography angiography (CCTA) between 2019 and 2024 for the diagnosis or assessment of coronary artery disease (CAD), at four academic hospitals in Spain, the Netherlands, and France. All patients have comparator diagnostic data available, such as invasive coronary angiography (ICA) and/or other non-invasive imaging. No new data collection or interventions will be performed, and all analyses will be conducted offline on de-identified datasets
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Software Application for CAD AssessmentA novel on-premises diagnostic software integrating automated coronary stenosis detection, CT-derived fractional flow reserve (CT-FFR), and plaque quantification for evaluation of coronary artery disease (CAD) using coronary computed tomography angiography (CCTA) datasets. | Device | Cohort_1 |
Primary outcome
Diagnostic accuracy of CAD-RADS classification using the diagnostic software
Time frame: At study completion (expected March 2025)
Accuracy of the CAD-RADS category assigned by the software compared to expert adjudication using invasive coronary angiography (ICA) and/or other non-invasive imaging.
Reproducibility of CAD-RADS classification using the diagnostic software
Time frame: At study completion (expected March 2025)
Assessment of inter-reader and intra-reader reproducibility in CAD-RADS classification using the software, evaluated via kappa statistics and intraclass correlation coefficients (ICC), stratified by reader experience.
3 secondary outcomes
User satisfaction with the diagnostic software application
Time frame: After completion of image analysis (expected March 2025)
Accuracy of the software in predicting the need for percutaneous coronary intervention (PCI)
Time frame: At study completion (expected March 2025)
Proportion of invasive coronary angiographies (ICA) without PCI potentially avoidable based on software analysis
Time frame: At study completion (expected March 2025)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including imaging datasets and related diagnostic parameters, may be shared for additional analyses in compliance with GDPR and FAIR data principles. Data will be stored in secure, GDPR-compliant repositories and may be made available upon reasonable request following project completion and publication of main results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Candelas Pérez Del Villar Moro, PhD MD contact
Candelas Pérez Del Villar Moro, PhD MD principal investigator
Fundación de Investigación Biomédica de Salamanca (FIBSAL)
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atherosclerosis, run by Instituto de Investigación Biomédica de Salamanca at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candelas Pérez Del Villar Moro, PhD MD (+34 923 29 11 00 ext. 55789, mcperezvi@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of CAD-RADS classification using the diagnostic software (time frame: At study completion (expected March 2025)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.