Evaluating Atrial Fibrosis as a Predictor for Post-operative Atrial Fibrillation in Cardiac Surgery Patients
Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF
Tulane University · NCT05014802
This study is trying to see if the amount of atrial fibrosis in patients can help predict if they will have heart rhythm problems after heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 120 Years |
| Sex | All |
| Sponsor | Tulane University (other) |
| Locations | 3 sites (Covington, Louisiana and 2 other locations) |
| Trial ID | NCT05014802 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between baseline atrial fibrosis and the incidence of post-operative atrial fibrillation (POAF) in patients undergoing cardiac surgery. A total of 50 patients aged 40 and older, with no prior history of atrial arrhythmias, will undergo cardiac magnetic resonance imaging (MRI) to determine their Utah fibrosis stage. Following their surgeries, the incidence of atrial arrhythmias, in-hospital mortality, length of stay, and complication rates will be monitored and compared across different fibrosis stages. The study seeks to provide insights into how atrial fibrosis may influence surgical outcomes and healthcare costs.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 and older scheduled for cardiac surgery without a history of atrial arrhythmias.
Not a fit: Patients with a history of atrial arrhythmias or those under 40 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at higher risk for post-operative complications, allowing for better preoperative planning and management.
How similar studies have performed: While the specific approach of using baseline atrial fibrosis as a predictor for POAF is novel, related studies have explored the impact of atrial fibrosis on cardiac outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Covington, Louisiana and 2 other locations
- Lakeview Hospital — Covington, Louisiana, United States (RECRUITING)
- East Jefferson General Hospital — New Orleans, Louisiana, United States (RECRUITING)
- Washington University Barnes-Jewish Hospital — St Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Jamil Borgi, MD — Tulane University
- Study coordinator: Yara Menassa, MD
- Email: ymenassa@tulane.edu
- Phone: 504-316-2003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Atrial Arrhythmia, Atrial Flutter, Atrial Tachycardia, Atrial Fibrosis, Cardiac Magnetic Resonance Imaging, Cardiac surgery