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

NCT05014802 | Recruiting

• 1 other identifier: 2021-622
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Atrial Fibrillation; Atrial Arrhythmia; Atrial Flutter; Atrial Tachycardia

Keywords

Atrial Fibrosis; Cardiac Magnetic Resonance Imaging; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of atrial arrhythmia in patients after cardiac surgery

  The incidence of any atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia etc.) from after their surgical procedure to their discharge from the hospital. Atrial arrhythmia is defined as any abnormal atrial rhythm episode continuing for more than 30 seconds, starting immediately after the patient arrives at the post-operation ICU. All atrial arrhythmia starting after the operation will be monitored and recorded. This will be measured using continuous telemetry and/or serial ECG monitoring.

  2 weeks

Secondary Outcomes (9)

• Rate of in-hospital mortality

  2 weeks

• Hospital and Intensive Care Unit (ICU) length of stay (LOS)

  2 weeks

• Incidence of stroke

  2 weeks

• Incidence of acute respiratory failure

  2 weeks

• Incidence of sudden cardiac arrest

  2 weeks

Eligibility Criteria

• Age: 40 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is any patient with no history of atrial arrhythmia scheduled to undergo cardiac surgery and meets other inclusion/exclusion criteria). Each Site: * Approximately 10 Patients from either Tulane Medical Center and/or University Medical Center New Orleans. * Approximately 40 Patients from Washington University Medical Center (Barnes Jewish Hospital). The PIs and co-PI will have access to recruit patients through their cardiology and cardiothoracic surgery clinics. Participants may also be recruited from the community by direct advertising; emails, TV, flyers posted in public places, as well as online postings to study-site affiliated websites, social media platforms (Facebook, Twitter, Instagram) and LinkedIn.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead

Study Sites (3)

Lakeview Hospital

Covington, Louisiana, 70433, United States

RECRUITING

East Jefferson General Hospital

New Orleans, Louisiana, 70006, United States

RECRUITING

Washington University Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

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

Study Officials

• Jamil Borgi, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yara Menassa, MD

CONTACT

504-316-2003; ymenassa@tulane.edu

Kunal Sameer, MD, MHA

CONTACT

504-988-3072; ksameer@tulane.edu

Study Design

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

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: November 21, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (3)