[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561820":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":36,"responsibleParty":129,"collaborators":132,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":10,"enrollmentInfo":145,"targetDuration":10,"studyType":148,"phases":10,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":71,"whyStopped":10,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"University Hospital, Bonn","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1",null,"Standard Care plus Fitnesstracker and Citizen App",[13],"Other: Non Interventional",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2","Standard Care",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Non Interventional","Screening (Day -7 to Day -1) Visit 1 (Day 0) Visit 2 (Month 3 +\u002F- 7 days) Visit 3 (Month 6 +\u002F- 7 days) Visit 4 (Month 12 +\u002F- 7 days) Visit 5 (Month 24 +\u002F- 7 days) Visit 6 (Month 60 +\u002F- 30 days; end of study)",[9,15],[24],{"name":25,"affiliation":26,"role":27},"Ulrike Attenberger, Prof. Dr.","ulrike.attenberger@meduniwien.ac.at","PRINCIPAL_INVESTIGATOR",[29,32],{"name":25,"role":30,"phone":31,"phoneExt":10,"email":26},"CONTACT","+43 (0)140400-48930",{"name":33,"role":30,"phone":34,"phoneExt":10,"email":35},"Wiebke Fenske, Prof. Dr.","0234 302 6400","Wiebke.Fenske@bergmannsheil.de",[37,54,69,84,101,114],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Medical University Vienna","NOT_YET_RECRUITING","Vienna","1090","Austria","AT",{"type":45,"coordinates":46},"Point",[47,48],16.37208,48.20849,{"lat":48,"lon":47},[51],{"name":52,"role":30,"phone":10,"phoneExt":10,"email":53},"Christian Loewe, Prof. Dr.","christian.loewe@meduniwien.ac.at",{"facility":55,"status":39,"city":56,"state":10,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"University Hospital Leuven","Leuven","3000","Belgium","BE",{"type":45,"coordinates":61},[62,63],4.70093,50.87959,{"lat":63,"lon":62},[66],{"name":67,"role":30,"phone":10,"phoneExt":10,"email":68},"Hilde Bosmans, Prof.","hilde.bosmans@kuleuven.be",{"facility":70,"status":71,"city":72,"state":10,"zip":73,"country":74,"countryCode":10,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University Hospital Pilsen","RECRUITING","Pilsen","323 00","Czechia",{"type":45,"coordinates":76},[77,78],13.37759,49.74747,{"lat":78,"lon":77},[81],{"name":82,"role":30,"phone":10,"phoneExt":10,"email":83},"Jiri Ferda, Prof. Dr.","ferda@fnplzen.cz",{"facility":85,"status":71,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"University Hospital Bonn","Bonn","North Rhine-Westphalia","53127","Germany","DE",{"type":45,"coordinates":92},[93,94],7.09549,50.73438,{"lat":94,"lon":93},[97,100],{"name":25,"role":30,"phone":98,"phoneExt":10,"email":99},"0228 287 15871","Ulrike.Attenberger@ukbonn.de",{"name":33,"role":30,"phone":34,"phoneExt":10,"email":35},{"facility":102,"status":71,"city":103,"state":10,"zip":104,"country":89,"countryCode":90,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"University Hospital Mannheim","Mannheim","68167",{"type":45,"coordinates":106},[107,108],8.46694,49.4891,{"lat":108,"lon":107},[111],{"name":112,"role":30,"phone":10,"phoneExt":10,"email":113},"Stefan Schönberg, Prof. Dr.","stefan.schoenberg@umm.de",{"facility":115,"status":39,"city":116,"state":10,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"University Hospital Zürich","Zurich","8091","Switzerland","CH",{"type":45,"coordinates":121},[122,123],8.55,47.36667,{"lat":123,"lon":122},[126],{"name":127,"role":30,"phone":10,"phoneExt":10,"email":128},"Hatem Alkadhi, Prof. Dr.","hatem.alkadhi@usz.ch",{"type":27,"investigatorFullName":130,"investigatorTitle":131,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Prof. Dr. Ulrike Attenberger","Director, Clinic for Diagnostik and Interventional Radiology",[133],{"name":134,"class":6},"European Union","100561820","ai-pod-clinical-validation-study-for-obese-patients-100561820",false,"NCT06595134","AI-POD Clinical Validation Study for Obese Patients","AI for the Prediction of Obesity-Related Vascular Diseases - Validation Study","AI-POD","Inclusion Criteria:\n\n* Age greater than or equal to 45 years at the time of signing informed consent\n* BMI greater than or equal to 30 kg\u002Fm2\n* Patients with suspected CVD (\\>15% pretest probability \\[ESC guidelines\\]), referred for cardiac CT examinations (consisting of coronary calcium scoring and coronary CT angiography)\n* Informed consent of the patient\n\nExclusion Criteria:\n\n* Any of the following CV conditions within 2 months prior to study inclusion: myocardial infarction, stroke,\n* Hospitalization for unstable angina pectoris or transient ischemic attack or due to congestive heart failure.\n* Planned coronary, carotid, or peripheral artery revascularisation known on the day of inclusion\n* Presently classified NYHA IV heart failure\n* Having uncontrolled diabetes mellitus (HbA1c ≥ 11%) at day of inclusion\n* Having uncontrolled hypertension (SBP ≥ 160 mmHg and\u002For DBP ≥ 100 mmHg) as measured at inclusion\n* Having severe renal impairment measured as an eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 at inclusion\n* Alanine aminotransferase (ALT) or alkaline phosphatase (APT) level \\\u003C 3.0 x the upper limit of normal (ULN)for the reference range\n* Total bilirubin level \\>1.5 x the ULN for the reference range\n* History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years\n* Previous organ transplantation or awaiting an organ transplant\n* Pregnancy or breastfeeding","ALL","45 Years",{"count":146,"type":147},1200,"ESTIMATED","OBSERVATIONAL","The study is aimed at patients who suffer from severe obesity and receive a computerised tomography (CT) scan of the heart. A total of 1200 patients across Europe are to take part in the study. It is a multi-centre, controlled, open, randomised study. As part of the study, a citizen app will be installed on a smartphone for randomly selected study participants. A fitness tracker will also be issued so that certain parameters, such as heart rate and daily number of steps, can be recorded.",[151],"Acute Cardiovascular Disease",[153],"Obesity, Heart CT, Artificial Intelligence","2024-09-10",{"date":156,"type":157},"2024-09-19","ACTUAL",{"date":159,"type":157},"2024-07-01",{"date":161,"type":147},"2028-07",{"name":5,"class":6},6]