[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619498":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":33,"locations":43,"responsibleParty":61,"collaborators":64,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":10,"enrollmentInfo":85,"targetDuration":88,"studyType":89,"phases":10,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":109,"whyStopped":10,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Medical University of Gdansk","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Elective Cardiac Surgery Patients",null,"Adult men and women (≥18 years) undergoing elective cardiac surgery who provide informed consent are enrolled. Patients with a history of, or planned, solid organ or bone marrow transplantation are excluded. All participants are followed prospectively during and after surgery to determine the occurrence of early postoperative complications, including new-onset atrial fibrillation, acute kidney injury, postoperative delirium, vasoplegia, and postoperative bleeding, as well as in-hospital and 30-day mortality, duration of mechanical ventilation, and ICU and hospital length of stay.",[13],"Other: Multi-Omics Data and Clinical Data Collection",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Multi-Omics Data and Clinical Data Collection","Collection of blood, urine, stool, imaging data, intraoperative data, and non-invasive digital recordings (voice and video) for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, laboratory, and clinical analyses. No therapeutic intervention is given. All procedures involve observational data and biospecimen collection before, during, and after elective cardiac surgery.",[9],[20],"Biological Sample Collection",[22,26,30],{"name":23,"affiliation":24,"role":25},"Maciej M Kowalik, MD, PhD, Dsc","Medical University of Gdansk, Department of Anesthesiology and Intensive Care","STUDY_DIRECTOR",{"name":27,"affiliation":28,"role":29},"Radosław Owczuk, Prof. dr hab.","Medical University fo Gdańsk, Department of Anetshesiology and Intensive Care","STUDY_CHAIR",{"name":31,"affiliation":24,"role":32},"Kowalik M Kowalik, MD, PhD, Dsc","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Maciej Kowalik, MD, PhD, DSc","CONTACT","+48585846109","mkowalik@gumed.edu.pl",{"name":40,"role":36,"phone":41,"phoneExt":10,"email":42},"Maciej Brzeziński, MD, PhD, Dsc","+585844200","mbrzez@gumed.edu.pl",[44],{"facility":45,"status":10,"city":46,"state":10,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University Clinical Centre Gdansk, Department of Anaesthesiology and Intensive Care","Gdansk","80-952","Poland","PL",{"type":51,"coordinates":52},"Point",[53,54],18.64912,54.35227,{"lat":54,"lon":53},[57],{"name":58,"role":36,"phone":59,"phoneExt":10,"email":60},"Maciej Kowalik, MD, PhD","+48583493270","anestezjologia@uck.gda.pl",{"type":32,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Maciej M. Kowalik, MD, PhD, DSc","Principal Investigator",[65,68,70,72,74],{"name":66,"class":67},"Politechnika Gdańska","UNKNOWN",{"name":69,"class":67},"University of Gdańsk",{"name":71,"class":6},"Pomeranian Medical University Szczecin",{"name":73,"class":6},"Silesian University of Medicine",{"name":75,"class":67},"AGH University of Science and Technology, Krakow, Poland","100619498","genecard---the-use-of-genetic-epigenetic-metabolomic-proteomic-and-microbiotic-markers-image-and-voice-biomarker-analyses-and-pre--and-intraoperative-clinical-data---to-predict-early-complications-after-cardiac-surgery-100619498",false,"NCT07345403","GENECARD - the Use of Genetic, Epigenetic, Metabolomic, Proteomic and Microbiotic Markers, Image and Voice Biomarker Analyses, and Pre- and Intraoperative Clinical Data - to Predict Early Complications After Cardiac Surgery.","GENECARD","Inclusion Criteria:\n\n* Adults (≥18 years old)\n* Undergoing elective cardiac surgery\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Age below 18 years\n* Lack of informed consent\n* Prior or planned solid organ transplantation\n* Prior or planned bone marrow transplantation","ALL","18 Years",{"count":86,"type":87},3000,"ESTIMATED","30 Days","OBSERVATIONAL","The goal of this observational cohort study is to prove whether genetic, epigenetic, transcriptomic, proteomic, metabolomic, imaging, voice, and clinical markers can improve prediction of early complications after cardiac surgery in adult patients.\n\nThe main questions it aims to answer are:\n\nWhich biological and clinical markers are associated with: new-onset atrial fibrillation (NOAF), acute kidney injury (AKI), postoperative delirium (POD), vasoplegia, postoperative bleeding and 30-day mortality? Can combining these markers improve early prediction of postoperative complications compared with current clinical risk scores?\n\nResearchers will analyze a wide range of data collected before, during, and after cardiac surgery and compare patients who develop early complications with those who do not to identify risk factors and early biomarkers.\n\nParticipants will:\n\nProvide biological samples (blood, urine, stool) before and after surgery for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, and laboratory testing.\n\nUndergo standard preoperative and intraoperative imaging and clinical assessments.\n\nAllow collection of clinical data related to postoperative outcomes (For some participants) have voice and video recordings performed to help identify early signs of postoperative delirium.\n\nThis study aims to improve early detection of postoperative complications and support development of personalized diagnostic and treatment strategies for patients undergoing cardiac surgery.",[92,93,94,95,96],"Postoperative Delirium (POD)","Postoperative Bleeding","Acute Kidney Injury","Atrial Fibrillation (AF)","Vasoplegia",[98,99,100,94,101,96,102,103,104,105,106,107,108],"Cardiac Surgery","Postoperative Complications","Atrial Fibrillation","Postoperative Delirium","Biomarkers","Multi-omics","Risk Prediction","Epigenetics","genetics","microbiota","metabolomics","NOT_YET_RECRUITING","2026-01-08",{"date":112,"type":113},"2026-01-15","ACTUAL",{"date":115,"type":87},"2026-01-01",{"date":117,"type":87},"2029-12-31",{"name":5,"class":6},1]