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Completed

NCT Number: NCT06952179

Pericardial Histopathology and COVID-19 Seropositivity

This prospective study aims to investigate the association between pericardial histopathologic inflammation grades (acute, chronic, or absent) and COVID-19 seropositivity in adult patients undergoing first-time isolated coronary artery bypass grafting (CABG). Pericardial tissue samples were collected during surgery and evaluated histopathologically, while preoperative COVID-19 serological testing was performed. The primary outcome is to determine whether COVID-19 seropositivity is associated with the severity of pericardial inflammation. Patients with prior cardiac surgery, active COVID-19 infection, systemic inflammatory diseases, chronic immunosuppressive therapy, or malignancy were excluded from the study.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsun University Faculty of Medicine

Samsun, 55090, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥20 years
  • Undergoing first-time isolated coronary artery bypass grafting (CABG)
  • Availability of pericardial tissue sample for histopathological analysis
  • Preoperative COVID-19 serological testing performed
  • Written informed consent obtained

Exclusion criteria

  • Previous history of cardiac surgery (e.g., prior CABG, valve surgery)
  • Concomitant cardiac procedures during the same operation (e.g., valve repair, aortic surgery)
  • Active COVID-19 infection at the time of surgery (positive PCR test)
  • Known autoimmune or systemic inflammatory diseases (e.g., lupus, rheumatoid arthritis)
  • Chronic immunosuppressive therapy (e.g., steroids, biologics)
  • Known malignancy at the time of surgery

Insufficient or inadequate pericardial tissue sample for histopathological assessment

Treatment and study plan

Primary outcomes

  1. Pericardial inflammation histopatalogical evaluation

    Time frame: up to 1 year

    prospective evaluation of the relationship between pericardial inflammation grade (0: absent, 1: mild, 2: moderate, 3: severe) and COVID-19 seropositivity in adult patients undergoing first-time coronary artery bypass grafting. The primary outcome of this study is to investigate the association between pericardial inflammation grade, as determined by histopathological evaluation (categorized as acute, chronic, or absent inflammation), and COVID-19 seropositivity in adult patients undergoing first-time coronary artery bypass grafting.

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Pericardial Histopathology and COVID-19 Seropositivity in Adult Patients Undergoing First-Time Coronary Artery Bypass Grafting: A Prospective Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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