Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
NCT ID: NCT05014802
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2021-11-21
2026-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
120 Years
ALL
No
Sponsors
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Tulane University
OTHER
Responsible Party
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Principal Investigators
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Nassir Marrouche, MD
Role: PRINCIPAL_INVESTIGATOR
Tulane University
Locations
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Tulane University Medical Center
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Washington University Barnes-Jewish Hospital
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Quintrele Jones, MPH
Role: primary
Chris Wang, MS
Role: backup
Quintrele Jones, MPH
Role: primary
Chris Wang, MS
Role: backup
Marci Damiano, RN, MSN
Role: primary
Other Identifiers
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2021-622
Identifier Type: -
Identifier Source: org_study_id