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)

January 8, 2026 updated by: Maciej M. Kowalik, MD, PhD, DSc, Medical University of Gdansk

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Single-center, prospective, translational, observational cohort study designed to identify markers that predict early postoperative complications in adult patients undergoing elective cardiac surgery. The study will analyze genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, imaging, voice, and detailed clinical data collected before, during, and after surgery. Approximately 2,000-3,000 participants will be enrolled between 2026 and 2029.

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Gdansk, Poland, 80-952
        • University Clinical Centre Gdansk, Department of Anaesthesiology and Intensive Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing elective cardiac surgery at a single center. Participants include men and women who consent to provide clinical data and biospecimens for analysis. Individuals under 18 years of age or with prior or planned organ or bone marrow transplantation are excluded.

Description

Inclusion Criteria:

  • Adults (≥18 years old)
  • Undergoing elective cardiac surgery
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Age below 18 years
  • Lack of informed consent
  • Prior or planned solid organ transplantation
  • Prior or planned bone marrow transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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 Names:
  • Biological Sample Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New-onset atrial fibrillation (NOAF)
Time Frame: From end of surgery until hospital discharge, up to 14 days.
Occurrence of new-onset atrial fibrillation after cardiac surgery, defined according to current ESC guidelines, using clinical data, ECG and centrally recorded rhythm data.
From end of surgery until hospital discharge, up to 14 days.
Acute kidney injury (AKI)
Time Frame: From end of surgery until hospital discharge, up to 14 days.
Occurrence of acute kidney injury after cardiac surgery, defined according to KDIGO criteria, using serial laboratory measurements (including serum creatinine and other kidney biomarkers).Early postoperative period after cardiac surgery during index hospitalization.
From end of surgery until hospital discharge, up to 14 days.
Postoperative delirium (POD)
Time Frame: From end of surgery until hospital discharge, up to 14 days.
Occurrence of postoperative delirium after cardiac surgery, defined according to DSM-V criteria and assessed with validated delirium scales (e.g., CAM-ICU or DOSS), clinical observation, and supporting data (including voice and image recordings in selected patients).
From end of surgery until hospital discharge, up to 14 days.
Vasoplegia
Time Frame: Perioperative period and postoperative hospitalization, up to 14 days.
Occurrence of vasoplegia after cardiac surgery, identified from perioperative and postoperative hemodynamic and clinical data according to prespecified criteria in the protocol.
Perioperative period and postoperative hospitalization, up to 14 days.
Postoperative bleeding
Time Frame: Within 24 hours after surgery and during hospitalization for re-exploration, up to 14 days.
Occurrence of significant postoperative bleeding after cardiac surgery, defined as blood loss >1000 mL in chest drains within 24 hours or the need for surgical re-exploration due to bleeding.
Within 24 hours after surgery and during hospitalization for re-exploration, up to 14 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: From date of surgery until hospital discharge or death, up to 14 days.
Death from any cause occurring during the index hospitalization after cardiac surgery.
From date of surgery until hospital discharge or death, up to 14 days.
30-day mortality
Time Frame: 30 days after surgery.
Death from any cause within 30 days after cardiac surgery, assessed through hospital records and follow-up.
30 days after surgery.
Duration of mechanical ventilation
Time Frame: From end of surgery until final extubation, up to 7 days.
Total duration of postoperative invasive mechanical ventilation, measured in hours, based on clinical and ICU records.
From end of surgery until final extubation, up to 7 days.
ICU length of stay
Time Frame: From ICU admission after surgery until ICU discharge, up to 7 days.
Duration of postoperative stay in the intensive care unit, measured in days, based on clinical records.
From ICU admission after surgery until ICU discharge, up to 7 days.
Postoperative hospital length of stay
Time Frame: From date of surgery until hospital discharge, up to 14 days.
Total length of postoperative hospitalization, measured in days, based on clinical records.
From date of surgery until hospital discharge, up to 14 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Collaborators

Pomeranian Medical University Szczecin
Silesian University of Medicine
AGH University of Science and Technology, Krakow, Poland
University of Gdańsk
Politechnika Gdańska

Investigators

  • Study Director: Maciej M Kowalik, MD, PhD, Dsc, Medical University of Gdansk, Department of Anesthesiology and Intensive Care
  • Study Chair: Radosław Owczuk, Prof. dr hab., Medical University fo Gdańsk, Department of Anetshesiology and Intensive Care
  • Principal Investigator: Kowalik M Kowalik, MD, PhD, Dsc, Medical University of Gdansk, Department of Anesthesiology and Intensive Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/470/2025
  • 064/2025 (Other Identifier: University Clinical Center (Uniwersyteckie Centrum Kliniczne; UCK) Gdańsk, Poland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual data planed for sharing will include:

  1. anamnesis and structured forms derived data
  2. comorbdities and chronic therapies
  3. laboratory results of blood, urine and other bio specimen exams
  4. genotyped SNP's associated with primary outcome measures
  5. others

IPD Sharing Time Frame

Beginning 6 months after starting the recruitment and ending 3 years after last participant recruited.

IPD Sharing Access Criteria

Data are planned to be set for open access without restrictions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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