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NCT06977295: CODEX1
Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
trial testing Diagnostic Software Application for CAD Assessment in Coronary Artery Disease in 1,000 participants. Participants enrolled and being followed up; not accepting new ones.
31 March 2025
Quick facts
| Lead sponsor | Instituto de Investigación Biomédica de Salamanca |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 23 September 2024 |
| Primary completion | 31 March 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 4 locations across France, Netherlands, Spain |
Drugs / interventions tested
- Diagnostic Software Application for CAD Assessment
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Atherosclerosis — all drugs for Atherosclerosis →
- Myocardial Ischemia — all drugs for Myocardial Ischemia →
Sponsor
Instituto de Investigación Biomédica de Salamanca — full company profile →
Who can join
18 and older, any sex, with Coronary Artery Disease or Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06977295
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06977295 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto de Investigación Biomédica de Salamanca
- Last refreshed: 18 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06977295.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing