RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF

Quick Facts

Study Start:2021-11-21
Study Completion:2024-07-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05014802

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female patients age 40 years of age or older
  2. * 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).
  1. * Patients with a history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia)
  2. * Patients with a history of cardiac or open chest surgery
  3. * Patients with a history of catheter ablation
  4. * Patients under the age of 40
  5. * Patients with left ventricular assist device (LVAD) or scheduled to have LVAD implanted
  6. * Patients who have previously undergone extracorporeal membrane oxygenation (ECMO)
  7. * Patients who have undergone or will undergo heart transplantation
  8. * 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)
  9. * 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).
  10. * Patients weighing \> 300 lbs. (MRI image quality decreases due to increased body mass index)
  11. * Patients currently pregnant or breastfeeding, or plan to become pregnant during the study period
  12. * Patients with cognitive impairment preventing them from giving informed consent will be excluded from the study
  13. * Patients who cannot read, speak, and/or understand English

Contacts and Locations

Study Contact

Quintrele Jones, MPH
CONTACT
504-988-3063
qjones1@tulane.edu
Chris Wang, MS
CONTACT
504-988-3065
hwang37@tulane.edu

Principal Investigator

Nassir Marrouche, MD
PRINCIPAL_INVESTIGATOR
Tulane University

Study Locations (Sites)

Tulane University Medical Center
New Orleans, Louisiana, 70112
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
Washington University Barnes-Jewish Hospital
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Tulane University

  • Nassir Marrouche, MD, PRINCIPAL_INVESTIGATOR, Tulane University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-21
Study Completion Date2024-07-25

Study Record Updates

Study Start Date2021-11-21
Study Completion Date2024-07-25

Terms related to this study

Keywords Provided by Researchers

  • Atrial Fibrosis
  • Cardiac Magnetic Resonance Imaging
  • Cardiac surgery

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Atrial Arrhythmia
  • Atrial Flutter
  • Atrial Tachycardia