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NCT07345403Not yet recruiting

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.

Source: ClinicalTrials.gov · Last updated 15 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
3000 (estimated)
First submitted
7 Dec 2025
Start date
1 Jan 2026
Primary completion date
31 Dec 2029
Lead sponsor
Medical University of Gdansk
NCT number
NCT07345403

What you commit to

  • Study type: Observational
  • Planned participants: 3000
  • From 1 Jan 2026 to the primary completion date, 31 Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior or planned solid organ transplantation
  • Prior or planned bone marrow transplantation

Age

  • Age below 18 years

Other

  • Lack of informed consent

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Clinical Centre Gdansk, Department of Anaesthesiology and Intensive Care
Coordinator of this site? Confirm its status
GdanskPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.