Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-120
SponsorTulane University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
2 weeksSecondary outcomes
1
Rate of in-hospital mortality
In-hospital mortality is defined as patient death during any point of hospital stay following cardiac surgery. This will be measured through patients medical chart review.
Time frame
2 weeks2
Hospital and Intensive Care Unit (ICU) length of stay (LOS)
LOS is defined as duration from admission to discharge in days in the hospital and ICU. This will be measured through patients medical chart review.
Time frame
2 weeks3
Incidence of stroke
Stroke is defined as sudden loss of brain function caused by an interruption of blood supply to the brain either through an ischemic or hemorrhagic modality. This will be measured through patients medical chart review.
Time frame
2 weeks4
Incidence of acute respiratory failure
Acute respiratory failure is any decrease in respiratory function resulting in hypoxemia (low arterial oxygen levels), hypercapnia (elevated levels of carbon dioxide gas) or a combination of the two. This will be measured through patients medical chart review.
Time frame
2 weeksSponsors and contacts
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Source ClinicalTrials.gov