[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576372":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":44,"collaborators":19,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":19,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":19,"maxAge":53,"enrollmentInfo":54,"targetDuration":19,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":19,"overallStatus":31,"whyStopped":19,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Endomyocardial biopsy and analysis for the presence of dd-cfDNA","Whenever a patient enrolled in the study undergoes endomyocardial biopsy, either as part of surveillance of acute myocardial rejection or for clinical suspicion of rejection, concomitantly a blood sample will be taken and analyzed for the presence of dd-cfDNA. In patients with biopsy evidence of acute rejection, a new dd-cfDNA sampling will be performed approximately three months after treatment at the next clinical follow-up",[12],"Genetic: Evaluation of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA)",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"GENETIC","Evaluation of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA)","From the blood samples taken, 2 mL of plasma separated from blood will be stored in EDTA frozen at -80°C. This material will later be processed by NGS run using of CareDX kits. The result will be provided by dedicated software as percentage of donor DNA in relation to recipient DNA.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Luca Ragni, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","0512149024","luca.ragni@aosp.bo.it",[30],{"facility":5,"status":31,"city":32,"state":19,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Bologna","40138","Italy","IT",{"type":37,"coordinates":38},"Point",[39,40],11.33875,44.49381,{"lat":40,"lon":39},[43],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},{"type":45,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100576372","search-for-noninvasive-markers-of-graft-injury-in-pediatric-and-adult-patients-with-congenital-heart-disease-undergoing-cardiac-transplantation-100576372",false,"NCT06784440","Search for Noninvasive Markers of \"Graft Injury\" in Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Transplantation","Inclusion Criteria:\n\n* Adult patients with congenital heart disease undergoing cardiac transplantation at our center or other centers, followed in follow-up at our center (Unit of Pediatric Cardiology and Developmental Age, IRCCS Azienda Ospedaliero-Universitaria di Bologna)\n* Pediatric patients undergoing cardiac transplantation at our center or other centers but followed in follow-up at our center\n* Obtaining informed consent from the adult patient or parent\u002Fguardian in case of minor\n\nExclusion Criteria:\n\n* Failure to obtain informed consent from the adult patient or parent\u002Fguardian in case of minor","ALL","44 Years",{"count":55,"type":56},20,"ESTIMATED","INTERVENTIONAL",[59],"NA","This clinical tissue-based, drug-free, single-center, longitudinal study aims to validate a new diagnostic method, namely, to evaluate whether plasma levels of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA), in patients undergoing orthotopic heart transplantation, can be predictive of the presence of acute myocardial rejection with the same sensitivity as immunohistochemical analysis on endomyocardial biopsy specimen, the current gold standard for the diagnosis of acute cell-mediated myocardial rejection, in a population consisting of pediatric patients and adult patients with congenital heart disease undergoing orthotopic heart transplantation.",[62,63,64,65],"Congenital Heart Disease (CHD)","Heart Transplant Patients","Adult Congenital Heart Disease","Pediatric Congenital Heart Disease","2025-01-14",{"date":68,"type":69},"2025-01-20","ACTUAL",{"date":71,"type":69},"2023-03-08",{"date":73,"type":56},"2026-03-07",{"name":5,"class":6},1]