Inflammatory ResponseNCT06952179
Pericardial Histopathology and COVID-19 Seropositivity
An observational study of Inflammatory Response and COVID-19, run by Samsun University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Inflammatory Response, COVID-19, Pericardial Disease
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University Faculty of Medicine
Samsun, 55090
About this study
Official title: Pericardial Histopathology and COVID-19 Seropositivity in Adult Patients Undergoing First-Time Coronary Artery Bypass Grafting: A Prospective Study
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
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- emrah ereren, Study chair, samsun university Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952179
- Sponsor's protocol ID
- kvcsamsun
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericardial Histopathology and COVID-19 Seropositivity in Adult Patients Undergoing First-Time Coronary Artery Bypass Grafting: A Prospective Study
- ClinicalTrials.gov ID
- NCT06952179
- Acronym / sponsor ID
- kvcsamsun
- Conditions
- Inflammatory Response, COVID-19, Pericardial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
emrah ereren study chair
samsun university Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Response and COVID-19, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pericardial inflammation histopatalogical evaluation (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.