Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)

NCT06977295 | Recruiting

• 2 other identifiers: CODEX1 TRIALPI 2024 09 1728
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 4

Brief 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. 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.

Conditions

Coronary Artery Disease; Atherosclerosis; Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At study completion (expected March 2025)

Secondary Outcomes (3)

• User satisfaction with the diagnostic software application

  After completion of image analysis (expected March 2025)

• Accuracy of the software in predicting the need for percutaneous coronary intervention (PCI)

  At study completion (expected March 2025)

• Proportion of invasive coronary angiographies (ICA) without PCI potentially avoidable based on software analysis

  At study completion (expected March 2025)

Study Arms (1)

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

Device: Diagnostic Software Application for CAD Assessment

Interventions

Diagnostic Software Application for CAD Assessment DEVICE

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.

Cohort_1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

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

Sponsors & Collaborators

• Instituto de Investigación Biomédica de Salamanca: lead

Study Sites (4)

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, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Candelas Pérez Del Villar Moro, PhD MD

  Fundación de Investigación Biomédica de Salamanca (FIBSAL)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candelas Pérez Del Villar Moro, PhD MD

CONTACT

+34 923 29 11 00; mcperezvi@saludcastillayleon.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (2); ES (1); FR (1)