[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627858":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":12,"centralContacts":28,"locations":37,"responsibleParty":53,"collaborators":12,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":12,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":12,"overallStatus":77,"whyStopped":12,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Fundacion Clinic per a la Recerca Biomédica","OTHER",[8,13,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Retrospective cohort (2018-2025)","NO_INTERVENTION","Patients with a confirmed CVDIs who underwent FDG-PET for diagnosis or follow-up. The retrospective cohort will include patients from 2018 to 2025 who have already undergone FDG-PET imaging and for whom complete clinical, microbiological, and therapeutic data are available.\n\nThese data were collected under a previously approved protocol with CEIm (Clinical Research Ethics Committee) authorization: HCB\u002F2015\u002F0769 and HCB\u002F2024\u002F1173.\n\nNo new procedures will be performed on retrospective patients; only a re-analysis of existing FDG-PET\u002FCT scans using radiomics techniques will be conducted.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"Prospective cohort (2026-2027)","This cohort will include patients with a confirmed CVDI undergoing FDG-PET\u002FCT as part of standard clinical care. Patients will be included before performing any FDG-PET\u002FCT examination, which will be acquired after signing informed consent.\n\nAll diagnostic and therapeutic procedures, including antibiotic or SAT when indicated, will follow standard clinical practice and will not be influenced by the study.\n\nWritten informed consent will be obtained to authorize the use of their clinical and imaging data for research purposes.",{"label":17,"type":18,"description":19,"interventionNames":20},"Control group (prospective)","EXPERIMENTAL","This group will include 40 patients with recently implanted cardiovascular devices and no clinical suspicion of infection, distributed as follows:\n\n* 10 pacemakers,\n* 10 valvular prostheses,\n* 10 vascular prostheses,\n* 10 transcatheter aortic valve implants (TAVIs)",[21],"Radiation: PET\u002FCT imaging",[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":12},"RADIATION","PET\u002FCT imaging","Inclusion will occur after device implantation and informed consent signature. FDG-PET\u002FCT imaging will be performed at approximately 1 month and 12 months post-implantation.\n\nThese patients will not receive any specific treatment related to the study, beyond the procedures planned in the study schedule to record potential adverse events related to FDG administration and to facilitate the communication of imaging results. All medical management will otherwise follow standard clinical practice.",[17],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":12,"email":33},"Marta Hernandez-Meneses, Dr","CONTACT","+34932775400","MHMENESES@clinic.cat",{"name":35,"role":31,"phone":32,"phoneExt":12,"email":36},"Maria Joyera","joyera@recerca.clinic.cat",[38],{"facility":39,"status":12,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hospital Clinic Barcelona","Barcelona","08036","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],2.15899,41.38879,{"lat":48,"lon":47},[51],{"name":52,"role":31,"phone":12,"phoneExt":12,"email":33},"Marta Hernández-Meneses, Dr.",{"type":54,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100627858","phase-4-application-of-radiomics-for-diagnosis-and-follow-up-of-cardiovascular-device-infections-predict-study-100627858",false,"NCT07454096","Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study","Application of Radiomics in Molecular Imaging (18F-FDG-PET\u002FCT) for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study","PREDICT","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Implanted cardiovascular device (prosthetic valve, TAVI, CIED, vascular graft\u002Fendograft).\n* For infected cohorts: patients studied by FDG-PET with definitive diagnosis of CVDI based on multidisciplinary evaluation.\n* For control group: no clinical suspicion of infection at time of inclusion.\n* Written Informed consent provided (prospective cohort and control group).\n* Women of child-bearing potential must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence (only if refraining from heterosexual intercourse during the period of twelve months of duration of the study).\n\nExclusion Criteria:\n\n* Inability to undergo FDG-PET due to contraindications (e.g., allergies, claustrophobia).\n* Pregnancy or breastfeeding.\n* Incomplete clinical data or lack of access to imaging studies.\n* Refusal or withdrawal of informed consent (for control and prospective cohort).",true,"ALL","18 Years","84 Years",{"count":68,"type":69},200,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","Single center, open-label, phase IV clinical trial to study the application of radiomics in molecular imaging for diagnosis and follow-up of CVDIs. The study will include three populations:\n\n* Retrospective cohort (2018-2025)\n* Prospective cohort (2026-2027)\n* Control group (prospective)",[75,76],"Cardiac Disease","Device Related Infection","NOT_YET_RECRUITING","2026-03-02",{"date":80,"type":81},"2026-03-06","ACTUAL",{"date":83,"type":69},"2026-04-30",{"date":85,"type":69},"2028-04-30",{"name":5,"class":6},1]