NCT06977295 Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
| NCT ID | NCT06977295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Biomédica de Salamanca |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-07-14 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Candelas Pérez Del Villar Moro, PhD MD
PRINCIPAL INVESTIGATOR
Fundación de Investigación Biomédica de Salamanca (FIBSAL)
Frequently Asked Questions
Who can join the NCT06977295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06977295 currently recruiting?
Yes, NCT06977295 is actively recruiting participants. Contact the research team at mcperezvi@saludcastillayleon.es for enrollment information.
Where is the NCT06977295 trial being conducted?
This trial is being conducted at Villeurbanne, France, Amsterdam, Netherlands, Amsterdam, Netherlands, Salamanca, Spain.
Who is sponsoring the NCT06977295 clinical trial?
NCT06977295 is sponsored by Instituto de Investigación Biomédica de Salamanca. The principal investigator is Candelas Pérez Del Villar Moro, PhD MD at Fundación de Investigación Biomédica de Salamanca (FIBSAL). The trial plans to enroll 1,000 participants.