[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591197":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":81,"collaborators":10,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":10,"enrollmentInfo":93,"targetDuration":10,"studyType":96,"phases":10,"briefSummary":97,"conditions":98,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Instituto de Investigación Biomédica de Salamanca","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort_1",null,"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\u002For other non-invasive imaging. No interventions are performed as part of this study",[13],"Device: Diagnostic Software Application for CAD Assessment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Diagnostic Software Application for CAD Assessment","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.",[9],[21],{"name":22,"affiliation":23,"role":24},"Candelas Pérez Del Villar Moro, PhD MD","Fundación de Investigación Biomédica de Salamanca (FIBSAL)","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","+34 923 29 11 00","55789","mcperezvi@saludcastillayleon.es",[32,47,60,68],{"facility":33,"status":34,"city":35,"state":10,"zip":10,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Université Lyon 1","RECRUITING","Villeurbanne","France","FR",{"type":39,"coordinates":40},"Point",[41,42],4.8795,45.76601,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":10,"phoneExt":10,"email":10},"Philippe Douek., MD PhD",{"facility":48,"status":34,"city":49,"state":10,"zip":10,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Amsterdam University Medical Center (AUMC)","Amsterdam","Netherlands","NL",{"type":39,"coordinates":53},[54,55],4.88969,52.37403,{"lat":55,"lon":54},[58],{"name":59,"role":27,"phone":10,"phoneExt":10,"email":10},"Nils Planken., MD PhD",{"facility":61,"status":34,"city":49,"state":10,"zip":10,"country":50,"countryCode":51,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Cardiologie Centra Nederland (CCM)",{"type":39,"coordinates":63},[54,55],{"lat":55,"lon":54},[66],{"name":67,"role":27,"phone":10,"phoneExt":10,"email":10},"Michiel Winter, MD PhD",{"facility":69,"status":34,"city":70,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Institute of Biomedical Research of Salamanca","Salamanca","37007","Spain","ES",{"type":39,"coordinates":75},[76,77],-5.66388,40.96882,{"lat":77,"lon":76},[80],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},{"type":82,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100591197","evaluation-of-a-diagnostic-software-for-coronary-artery-disease-using-retrospective-ccta-data-codex-1-study-100591197",false,"NCT06977295","Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)","CODEX1 TRIAL: Complete One-Stop-Shop Diagnosis Of Coronary Artery Disease On Computed Coronary Tomography Angiography: From the COMBINE-CT Study","CODEX1","Inclusion Criteria:\n\n* Age 18 years or older\n* Underwent coronary computed tomography angiography (CCTA) for the diagnosis or assessment of coronary artery disease (CAD) between 2019 and 2024\n* 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\n\nExclusion Criteria:\n\n\\- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use","ALL","18 Years",{"count":94,"type":95},1000,"ESTIMATED","OBSERVATIONAL","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\u002For 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.",[99,100,101],"Coronary Artery Disease","Atherosclerosis","Myocardial Ischemia","2026-04-20",{"date":104,"type":105},"2026-04-21","ACTUAL",{"date":107,"type":105},"2025-07-14",{"date":109,"type":95},"2027-04-30",{"name":5,"class":6},4]