Pericardial Histopathology and COVID-19 Seropositivity

NCT06952179 | Completed

• 1 other identifier: kvcsamsun
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Response; COVID-19; Pericardial Disease

Outcome Measures

Primary Outcomes (1)

• Pericardial inflammation histopatalogical evaluation

  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.

  up to 1 year

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study included adult patients (≥20 years) undergoing first-time isolated coronary artery bypass grafting (CABG). All patients had available pericardial tissue samples for histopathological evaluation and preoperative COVID-19 serological testing. Patients with prior cardiac surgery, active COVID-19 infection, systemic inflammatory diseases, chronic immunosuppressive therapy, or malignancy were excluded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University Faculty of Medicine

Samsun, 55090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• emrah ereren

  samsun university Faculty of medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: April 30, 2025
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

TU (1)