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

Launched by TULANE UNIVERSITY · Aug 13, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how certain changes in the heart, known as atrial fibrosis, might affect the likelihood of patients developing a common heart rhythm issue called Post-Operative Atrial Fibrillation (POAF) after heart surgery. The researchers believe that patients with more significant fibrosis will be at a higher risk of experiencing POAF. They will also track other important factors, such as how long patients stay in the hospital, how many complications they face (like strokes or pneumonia), and the overall costs of care between those who do and do not develop POAF.

To be eligible for this study, participants must be 40 years or older and have no prior history of atrial arrhythmias (like atrial fibrillation or flutter). They should also be scheduled for specific types of heart surgeries, such as bypass surgery or valve repair. Those who have had previous heart surgeries, certain medical devices, or conditions that might interfere with the study will not be included. Participants can expect to undergo assessments and tests related to their heart health and will contribute to understanding how fibrosis impacts recovery after surgery. This trial is currently recruiting participants, and your involvement could help improve care for future patients undergoing similar procedures.

Gender

ALL

Eligibility 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