Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Atrial Fibrillation Clinical Trial

Official title: Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF

Status Recruiting

Clinical Trial Summary

The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF.

The study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs.

Clinical Trial Description

The study is a a prospective, observational cohort study. 50 patients undergoing cardiac surgery (Coronary Artery Bypass Graft (CABG), valvular etc.) without a history of atrial fibrillation will be given a baseline Magnetic Resonance Imaging (MRI) upon which patients will be assigned Utah stages I-IV based on their left atrial fibrosis pattern. Overall fibrosis (%) of the left atrial wall area will also be collected. Patients will then undergo their planned surgeries receiving management adherent to current guidelines and standard of care procedures. Atrial arrhythmia incidence after surgical procedure will be collected using in-hospital telemetry or serial Electrocardiogram (ECG) from all patients in their respective cohorts. Cardiac surgery type, duration and any intraoperative complications will be recorded. Other clinical and relevant demographical data will be collected at admission and throughout patients' hospital stay.

All cardiac surgeries will be performed by experienced surgeons at Tulane Medical Center, Washington University Medical Center Barnes Jewish Hospital, and University Medical Center New Orleans, adhering to all relevant standard-of-care guidelines. MRI imaging will be performed by experienced technicians and operators at Tulane Medical Center, Washington University Medical Center Barnes Jewish Hospital, and University Medical Center New Orleans. MRI Utah fibrosis staging will be performed and assessed by experienced operators at MARREK, Inc., by using the Corview processing software with de-identified images.

The investigators expect a total recruitment of 50 subjects over a period of 6 months from the Tulane Medical Center Cardiology and Cardiothoracic Surgery Clinics, Washington University Medical Center Barnes Jewish Hospital Cardiology and Cardiothoracic Surgery Clinics, as well as University Medical Center New Orleans Cardiology and Cardiothoracic Surgery Clinics in order to complete the study. They expect to recruit 40 patients from Washington University Medical Center and 10 patients from either Tulane Medical Center or University Medical Center New Orleans. ;

Related Conditions & MeSH terms

• Atrial Arrhythmia
• Atrial Fibrillation
• Atrial Flutter
• Atrial Tachycardia
• Fibrosis
• Tachycardia

• NCT number: NCT05014802
• Study type: Observational
• Source: Tulane University
• Contact: Quintrele Jones, MPH
• Phone: 504-988-3063
• Email: qjones1@tulane.edu
• Status: Recruiting
• Start date: November 21, 2021
• Completion date: June 2024