Inflammation and Postoperative Atrial Fibrillation in Cardiac Surgery

NCT06475547 | Recruiting

• 1 other identifier: POAF130624
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, marked by an irregular and rapid heart rate, and associated with increased morbidity, longer hospital stays, and higher costs. Its complex pathophysiology involves atrial remodeling, inflammation, and autonomic dysregulation. Surgical trauma and cardiopulmonary bypass trigger an inflammatory response, releasing cytokines. Epicardial fat around the heart secretes pro-inflammatory cytokines, and its increased thickness is linked to higher inflammation and atrial fibrillation. This study uses RNA sequencing (RNA-seq) to profile gene expression in epicardial fat, identifying key genes involved in inflammation and metabolism. By comparing patients with and without POAF, RNA-seq reveals differentially expressed genes associated with postoperative atrial fibrillation.

Conditions

Atrial Fibrillation; Inflammation

Outcome Measures

Primary Outcomes (1)

• Differential expression of genes

  The primary endpoint of this study is to identify differentially expressed (DE) genes using RNA sequencing (RNA-seq) data. Post-sequencing, we will utilize the default settings and statistical methods provided by DESeq2 to determining statistically significant differences in gene expression between the experimental conditions. The gene signal is measured in normalized counts per kilobase or in Fragments Per Kilobase of transcript per Million mapped reads.

  The sample is taken at the time of surgery.

Study Arms (2)

POAF

Patients who develop postoperative atrial fibrillation.

Other: Descriptive

Non-POAF

Patients who do not develop postoperative atrial fibrillation.

Interventions

Descriptive OTHER

This study is observational and does not involve any clinical intervention. The primary procedure involves the collection of epicardial fat tissue samples. The collected samples are then processed and analyzed to compare inflammatory gene expression between the two groups. The analysis includes RNA sequencing to identify differentially expressed genes associated with atrial fibrillation and inflammation.

POAF

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing cardiac surgery

You may qualify if:

• Age \> 18
• Informed consent

You may not qualify if:

• Incompetent individuals
• Reoperation

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital, Cardiac Surgery Department

Odense, 5000, Denmark

RECRUITING

Related Publications (3)

• Dobin A, Davis CA, Schlesinger F, Drenkow J, Zaleski C, Jha S, Batut P, Chaisson M, Gingeras TR. STAR: ultrafast universal RNA-seq aligner. Bioinformatics. 2013 Jan 1;29(1):15-21. doi: 10.1093/bioinformatics/bts635. Epub 2012 Oct 25.

  PMID: 23104886 BACKGROUND

• Love MI, Huber W, Anders S. Moderated estimation of fold change and dispersion for RNA-seq data with DESeq2. Genome Biol. 2014;15(12):550. doi: 10.1186/s13059-014-0550-8.

  PMID: 25516281 BACKGROUND

• Wong CX, Ganesan AN, Selvanayagam JB. Epicardial fat and atrial fibrillation: current evidence, potential mechanisms, clinical implications, and future directions. Eur Heart J. 2017 May 1;38(17):1294-1302. doi: 10.1093/eurheartj/ehw045.

  PMID: 26935271 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Sample Type: Epicardial fat tissue samples. Collection Method: Epicardial fat samples were collected during elective cardiac surgery from patients undergoing their first-time procedure. Collection Procedure: Tissue was carefully excised from the epicardial fat depot around the heart during surgery.

MeSH Terms

Conditions

Atrial Fibrillation; Inflammation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lytfi Krasniqi, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lytfi Krasniqi, MD

CONTACT

65412404; Lytfi.Krasniqi@rsyd.dk

Study Design

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

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: January 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: TBA
• Access Criteria: To request access, contact Lytfi.Krasniqi@rsyd.dk. A signed data access agreement, compliant with regional legislation and data authority requirements, is required prior to data release.

Locations

DK (1)