[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530404":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":10,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":79,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"GE Healthcare","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DL-Based Vulnerable Plaque Detection and Assessment Tool",null,"Enrolled subjects will receive a clinically indicated CCTA and ICA with OCT within 10 days. At least two qualified CCTA radiologists will independently review and annotate the coronary plaques in the CCTA using their local post-processing tools. At least two trained OCT readers will review and annotate the coronary plaques in the ICA\u002FOCT using their local post-processing tools.\n\nThe original de-identified CCTA data will be inputted into the Vulnerable Plaque Detection and Assessment Tool. The tool will perform the automatic identification of the plaque location and characteristics. These results will be compared to assess the algorithm's performance.",[13],"Other: Deep Learning-based Vulnerable Plaque Detection and Assessment Tool",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"OTHER","Deep Learning-based Vulnerable Plaque Detection and Assessment Tool","Scanning requirements for the clinically indicated CCTA and ICA with OCT will be performed according to current site(s) guidelines and procedures. Administration of medications (such as contrast agents and potentially beta-blockers and other medications) will be given according to standard hospital care.\n\nThis is a prospective research study evaluating an investigational product. The tool's use is intended for research purposes and is not intended as a substitute for required medical care. The CCTA and ICA with OCT will be processed in real-time using the site's locally available post-processing tools in order to guide the subject's medical care. Once the ICA with OCT is complete, the de-identified CCTA data will be inputted in the investigational tool.\n\nThe clinically indicated CCTA and the ICA with OCT will both take approximately 1 hour and will take place within 10 days. No additional imaging is needed as part of the study.",[9],[21],{"name":22,"affiliation":5,"role":23},"Paul Deak","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Melissa Challman","CONTACT","8582213007","melissa.challman@gehealthcare.com",[31],{"facility":32,"status":10,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia","Pavia","Lombardy","27100","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],9.15917,45.19205,{"lat":42,"lon":41},[45,49],{"name":46,"role":27,"phone":47,"phoneExt":10,"email":48},"Pietro Broglia, MD","+39 0383 695682","pietro_broglia@asst-pavia.it",{"name":46,"role":27,"phone":10,"phoneExt":10,"email":10},{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[53],{"name":54,"class":55},"Azienda Socio-Sanitaria Territoriale di Pavia","UNKNOWN","100530404","feasibility-of-a-deep-learning-based-algorithm-for-non-invasive-assessment-of-vulnerable-coronary-plaque-100530404",false,"NCT06186336","Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque","FOCUS DL","Inclusion Criteria:\n\n1. Patients referred for a clinically indicated CCTA and ICA with OCT imaging examinations;\n2. Diagnosis of chronic coronary syndrome, known CAD, or stable angina; AND,\n3. Patients with ACS that may undergo a CCTA and not refer directly to the Cath lab for revascularization procedures.\n\nExclusion Criteria:\n\n1. Contradictions to contrast;\n2. Contraindications for beta blocker;\n3. BMI \\>30;\n4. High heart rate ≥75 BPM;\n5. Atrial Fibrillation;\n6. Arrythmia or irregular heartbeats;\n7. Any prior coronary revascularization;\n8. Presence of pacemaker or implantable cardioverter defibrillator; OR,\n9. Patients with TAVI\u002FTAVR.","ALL",{"count":65,"type":66},200,"ESTIMATED","OBSERVATIONAL","The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade.",[70,71,72,73],"Chronic Coronary Syndrome","Coronary Artery Disease","Stable Angina","Acute Coronary Syndrome",[75,76,77,78],"Coronary CT Angiography","Invasive Coronary Angiography","Optical Coherence Tomography","Vulnerable Coronary Plaque","NOT_YET_RECRUITING","2025-01-06",{"date":82,"type":83},"2025-01-07","ACTUAL",{"date":85,"type":66},"2025-01",{"date":87,"type":66},"2025-06",{"name":5,"class":6},1]