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.
NCT ID: NCT07345403
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
3000 participants
OBSERVATIONAL
2026-01-01
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Predicting Severe Cardiac Arrhythmias in the Perioperative Period Using AI-ECG
NCT07348991
Postoperative Arrhythmia and Preoperative Cardiac Function
NCT06999681
Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias
NCT01359683
Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm
NCT06654401
Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch
NCT05573633
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Objectives
The main objective is to determine whether selected biological and clinical markers can predict early postoperative complications, including:
New-onset atrial fibrillation (NOAF), Acute kidney injury (AKI), Postoperative delirium (POD), Vasoplegia, Postoperative bleeding 30-day mortality.
The study will use current clinical definitions: NOAF per ESC guidelines, AKI per KDIGO criteria, and POD per DSM-V, as well as validated delirium scales such as CAM-ICU or DOSS. Postoperative bleeding will be defined as \>1000 mL drainage in 24 hours or the need for surgical re-exploration.
Secondary outcomes include in-hospital mortality, 30-day mortality, duration of mechanical ventilation, ICU length of stay, and total postoperative hospital length of stay.
Participants
Eligible participants are adult men and women undergoing elective cardiac surgery who provide informed consent. Exclusion criteria are age \<18 years, lack of consent, and prior or planned organ or bone marrow transplantation.
Data and Sample Collection
The study will collect a broad set of data and biological materials, including:
Clinical data: detailed medical history, epidemiologic factors, disease history, physical exam parameters, perioperative clinical data, and postoperative complication data.
Genetic analysis: targeted sequencing of selected SNPs associated with primary outcomes using PCR-based arrays or NGS/WGS. DNA from PBMCs will be collected from all participants, with potential additional sequencing pending external funding. A replication cohort of 525 patients from the INFLACOR study will be used for confirmatory analyses.
Epigenetic profiling: genome-wide epigenetic marker profiling from PBMCs in matched case-control subgroups (approximately n=300 per group) for participants who develop primary outcomes. DNA methylation will be analyzed to develop an epigenetic risk index and integrated with genetic and clinical data.
Transcriptomics: RNA-seq of PBMCs collected before surgery, as well as short-chain RNA (scRNA) profiling from urine samples collected pre- and postoperatively to identify early markers of AKI.
Proteomics and metabolomics: untargeted and targeted analyses of plasma collected preoperatively and at two postoperative time points (6 hours and postoperative day 3). These analyses aim to identify and validate early biomarkers of primary complications.
Laboratory diagnostics: serial measurement of selected laboratory markers relevant to early complications, such as serum creatinine, NGAL, cystatin C, and novel biomarkers (e.g., KIM) using ELISA.
Microbiota and microbiome: metabolomic and metagenomic sequencing analyses on fractionated stool samples to characterize gut bacterial composition, extracellular vesicles, and metabolite profiles, using GC-MS and LC-MS/MS.
Imaging data: routine preoperative imaging including transthoracic echocardiography (TTE) and coronary angiography.
Voice and video biomarkers: for participants developing POD, continuous bedside-acquired video, audio, and sensor data will be analyzed to identify voice and image biomarkers (e.g., MFCC parameters) associated with prodromal delirium. Machine-learning models will be developed to support real-time detection of POD-related features.
Analytical Approach
The study will use multistage regression, machine-learning techniques, and AI-based modeling to identify predictors of both primary and secondary outcomes. Analyses will integrate genetic, environmental, preoperative, and intraoperative factors. One aim is to enhance existing clinical risk calculators for postoperative morbidity and mortality, such as STS-ACSD and EuroSCORE. The study expects improved discrimination of predictive models, targeting ROC-AUC values \>0.9 for mortality and \>0.8 for morbidity.
A polygenic risk score will also be developed to evaluate genetic contribution to variation in primary outcomes.
Expected Impact
The integrated multi-omics and clinical approach is expected to identify new pathophysiological mechanisms underlying early postoperative complications and potentially support development of novel preventive therapies. The study aims to facilitate personalized perioperative diagnostic and therapeutic strategies by improving early identification of high-risk patients undergoing cardiac surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Elective Cardiac Surgery Patients
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undergoing elective cardiac surgery
* Able and willing to provide informed consent
Exclusion Criteria
* Lack of informed consent
* Prior or planned solid organ transplantation
* Prior or planned bone marrow transplantation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Politechnika Gdańska
UNKNOWN
University of Gdańsk
UNKNOWN
Pomeranian Medical University Szczecin
OTHER
Silesian University of Medicine
OTHER
AGH University of Science and Technology, Krakow, Poland
UNKNOWN
Medical University of Gdansk
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maciej M. Kowalik, MD, PhD, DSc
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maciej M Kowalik, MD, PhD, Dsc
Role: STUDY_DIRECTOR
Medical University of Gdansk, Department of Anesthesiology and Intensive Care
Radosław Owczuk, Prof. dr hab.
Role: STUDY_CHAIR
Medical University fo Gdańsk, Department of Anetshesiology and Intensive Care
Kowalik M Kowalik, MD, PhD, Dsc
Role: PRINCIPAL_INVESTIGATOR
Medical University of Gdansk, Department of Anesthesiology and Intensive Care
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Clinical Centre Gdansk, Department of Anaesthesiology and Intensive Care
Gdansk, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
064/2025
Identifier Type: OTHER
Identifier Source: secondary_id
KB/470/2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.