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.

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.

Conditions

• Postoperative Delirium (POD)
• Postoperative Bleeding
• Acute Kidney Injury
• Atrial Fibrillation (AF)
• Vasoplegia

Interventions

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.

Sponsors & Collaborators

• Politechnika Gdańska

  collaborator UNKNOWN

• University of Gdańsk

  collaborator UNKNOWN

• Pomeranian Medical University Szczecin

  collaborator OTHER

• Silesian University of Medicine

  collaborator OTHER

• AGH University of Science and Technology, Krakow, Poland

  collaborator UNKNOWN

• Medical University of Gdansk

  lead OTHER

Principal Investigators

• Maciej M Kowalik, MD, PhD, Dsc · Medical University of Gdansk, Department of Anesthesiology and Intensive Care

• Radosław Owczuk, Prof. dr hab. · Medical University fo Gdańsk, Department of Anetshesiology and Intensive Care

• Kowalik M Kowalik, MD, PhD, Dsc · Medical University of Gdansk, Department of Anesthesiology and Intensive Care

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Poland

Study Locations