Status:
ACTIVE_NOT_RECRUITING
Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
Lead Sponsor:
Instituto de Investigación Biomédica de Salamanca
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
18+ years
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 app...
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 su...
Eligibility Criteria
Inclusion
- 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
- \- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use
Key Trial Info
Start Date :
September 23 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06977295
Start Date
September 23 2024
End Date
December 31 2025
Last Update
May 18 2025
Active Locations (4)
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1
Université Lyon 1
Villeurbanne, France
2
Amsterdam University Medical Center (AUMC)
Amsterdam, Netherlands
3
Cardiologie Centra Nederland (CCM)
Amsterdam, Netherlands
4
Institute of Biomedical Research of Salamanca
Salamanca, Spain, 37007