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.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Gdansk

About this trial

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.

Eligibility criteria

Qualifiers

Adults (≥18 years old)

Undergoing elective cardiac surgery

Able and willing to provide informed consent

Disqualifiers

Age below 18 years

Lack of informed consent

Prior or planned solid organ transplantation

Prior or planned bone marrow transplantation

Trial design

Treatments tested in this trial

  • Multi-Omics Data and Clinical Data Collection

Treatment groups

3,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

Medical University of Gdansk

Lead sponsor

Politechnika Gdańska

Collaborator

University of Gdańsk

Collaborator

Pomeranian Medical University Szczecin

Collaborator

Silesian University of Medicine

Collaborator

AGH University of Science and Technology, Krakow, Poland

Collaborator