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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Multi-Omics Data and Clinical Data Collection

    Other intervention

    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.

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: Elective Cardiac Surgery Patients1 intervention

Trial outcomes

Primary outcomes

1

New-onset atrial fibrillation (NOAF)

Occurrence of new-onset atrial fibrillation after cardiac surgery, defined according to current ESC guidelines, using clinical data, ECG and centrally recorded rhythm data.

Time frame
From end of surgery until hospital discharge, up to 14 days.
2

Acute kidney injury (AKI)

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.

Time frame
From end of surgery until hospital discharge, up to 14 days.
3

Postoperative delirium (POD)

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).

Time frame
From end of surgery until hospital discharge, up to 14 days.
4

Vasoplegia

Occurrence of vasoplegia after cardiac surgery, identified from perioperative and postoperative hemodynamic and clinical data according to prespecified criteria in the protocol.

Time frame
Perioperative period and postoperative hospitalization, up to 14 days.

Secondary outcomes

1

In-hospital mortality

Death from any cause occurring during the index hospitalization after cardiac surgery.

Time frame
From date of surgery until hospital discharge or death, up to 14 days.
2

30-day mortality

Death from any cause within 30 days after cardiac surgery, assessed through hospital records and follow-up.

Time frame
30 days after surgery.
3

Duration of mechanical ventilation

Total duration of postoperative invasive mechanical ventilation, measured in hours, based on clinical and ICU records.

Time frame
From end of surgery until final extubation, up to 7 days.
4

ICU length of stay

Duration of postoperative stay in the intensive care unit, measured in days, based on clinical records.

Time frame
From ICU admission after surgery until ICU discharge, up to 7 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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