[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555988":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":24,"responsibleParty":39,"collaborators":24,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":24,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":24,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":24,"overallStatus":61,"whyStopped":24,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":24},{"fullName":5,"class":6},"Royal Brompton & Harefield NHS Foundation Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with a diagnosis of cardiac rejection","ACTIVE_COMPARATOR","Based on heart muscle biopsy findings. Subjects must have no significant coronary disease within the last 12 months (with a confirmatory angiogram, computed tomography coronary angiogram, myocardial perfusion scan, cardiac magnetic resonance imagining, or other coronary ischaemia test.",[13],"Radiation: 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients with no evidence of cardiac rejection","Based on heart muscle biopsy findings",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"RADIATION","18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)","Each participant will prepare for their study PET CT by following an initial 18 hour of zero carbohydrate diet followed by another 18 hours of fasting (water allowed). After confirming preparation, each study participant will have a single rest rubidium and 18F-FDG PET CT scan.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Mansimran Dulay, MBBS MRCP","Royal Brompton and Harefield Hospital","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Owais Dar, MRCP MD(Res)","CONTACT","+44(0)1895828898","o.dar@rbht.nhs.uk",{"name":37,"role":33,"phone":34,"phoneExt":24,"email":38},"Ramey Assaf, MBBS BMedSci","r.assaf@rbht.nhs.uk",{"type":40,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100555988","a-pilot-study-evaluating-the-potential-of-18f-fluorodeoxyglucose-pet-ct-imaging-in-diagnosing-cardiac-rejection-100555988",false,"NCT06519240","A Pilot Study Evaluating the Potential of 18F Fluorodeoxyglucose PET-CT Imaging in Diagnosing Cardiac Rejection.","A Prospective Blinded Pilot Study Evaluating the Sensitivity and Specificity of 18F Fluorodeoxyglucose PET CT Imaging (a Non-invasive Imaging Tool) for the Diagnosis of Rejection in Heart Transplant Recipients.","Inclusion Criteria:\n\n* All heart transplant recipients with definite cardiac rejection or definite no rejection with evidence of no significant coronary disease within the last 12 months (e.g with any of the following tests (1)angiogram (2) CTCA (3) MPS (4) CMR (5) other coronary ischaemia test)\n\nExclusion Criteria:\n\n* Unable to have a PET CT scan or comply with the dietary protocol\n* Age less than 18 years old\n* Unable to consent\n* Presence of significant coronary disease or coronary ischaemia\n* Insulin dependent diabetics\n* Pregnant or breast feeding individuals",true,"ALL","18 Years","99 Years",{"count":53,"type":54},20,"ESTIMATED","INTERVENTIONAL",[57],"NA","This pilot study aims to assess whether 18F-FDG PET CT imaging has the potential in diagnosing cardiac rejection. The investigators aim to recruit 20 heart transplant subjects within two groups of 10 subjects each. One group will have participants with definite rejection and the other group will have participants with definite no rejection. Subjects will be placed into study groups based on their heart muscle biopsy, echocardiogram, clinical symptoms, ECG, and presence or absence of donor specific antibodies. Each group will then undertake a 18F-FDG PET CT scan to identify whether this imaging modality has a role in identifying cardiac rejection. The study subjects and the research team will be blinded to the results of the PET CT until the end of the study.",[60],"Cardiac Transplant Rejection","NOT_YET_RECRUITING","2024-07-22",{"date":64,"type":65},"2024-07-25","ACTUAL",{"date":67,"type":54},"2024-09-30",{"date":69,"type":54},"2026-10-02",{"name":5,"class":6}]