Pericardial Histopathology and COVID-19 Seropositivity

NCT ID: NCT06952179

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Response COVID-19 Pericardial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsun University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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emrah ereren

Role: STUDY_CHAIR

samsun university Faculty of medicine

Locations

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Samsun University Faculty of Medicine

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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kvcsamsun

Identifier Type: -

Identifier Source: org_study_id