Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Recruiting · NCT05014802 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tulane University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Male or female patients age 40 years of age or older
- Patients with no history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) scheduled to undergo cardiac surgery (These surgeries include but are not limited to coronary artery bypass graft (CABG), valvular repair/reconstruction, aneurysm repair, and insertion of pacemaker).
Exclusion criteria
- Patients with a history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia)
- Patients with a history of cardiac or open chest surgery
- Patients with a history of catheter ablation
- Patients under the age of 40
- Patients with left ventricular assist device (LVAD) or scheduled to have LVAD implanted
- Patients who have previously undergone extracorporeal membrane oxygenation (ECMO)
- Patients who have undergone or will undergo heart transplantation
- Patients with any health related Late Gadolinium Enhancement (LGE)-MRI contraindications (including previous allergic reaction to gadolinium, pacemakers, defibrillators, other devices/implants contraindicated for MRI)
- Acute or chronic severe renal disease with a low glomerular filtration rate (GFR), \<30 mL per minute per 1.73 m2 will be excluded from the trial. (A creatinine measurement should be available within the last 6 months. If not, a creatinine blood test will be drawn to assess for renal function before the MRI acquisition).
- Patients weighing \> 300 lbs. (MRI image quality decreases due to increased body mass index)
- Patients currently pregnant or breastfeeding, or plan to become pregnant during the study period
- Patients with cognitive impairment preventing them from giving informed consent will be excluded from the study
- Patients who cannot read, speak, and/or understand English
Where it is running
3 locations listed across 2 US states.
- Lakeview Hospital - Covington, Louisiana, United States
- East Jefferson General Hospital - New Orleans, Louisiana, United States
- Washington University Barnes-Jewish Hospital - St Louis, Missouri, United States