Clinical Trial

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.

Study acronym: GENECARD
Not Yet Recruiting
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Summary
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. The main questions it aims to answer are: Which 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? Researchers 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. Participants will: Provide biological samples (blood, urine, stool) before and after surgery for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, and laboratory testing. Undergo standard preoperative and intraoperative imaging and clinical assessments. Allow 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. This study aims to improve early detection of postoperative complications and support development of personalized diagnostic and treatment strategies for patients undergoing cardiac surgery.
Trial Details
NCT Number NCT07345403
Lead Sponsor Medical University of Gdansk
Collaborators: Politechnika Gdańska, University of Gdańsk, Pomeranian Medical University Szczecin, Silesian University of Medicine, AGH University of Science and Technology, Krakow, Poland
Conditions Postoperative Delirium (POD), Postoperative Bleeding, Acute Kidney Injury, Atrial Fibrillation (AF), Vasoplegia
Enrollment 3,000 participants
Start Date 2026-01-01
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-15