Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Atrial Fibrillation
- 发起方
- Tulane University
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Incidence of atrial arrhythmia in patients after cardiac surgery
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
The study is a a prospective, observational cohort study. 50 patients undergoing cardiac surgery (Coronary Artery Bypass Graft (CABG), valvular etc.) without a history of atrial fibrillation will be given a baseline Magnetic Resonance Imaging (MRI) upon which patients will be assigned Utah stages I-IV based on their left atrial fibrosis pattern. Overall fibrosis (%) of the left atrial wall area will also be collected. Patients will then undergo their planned surgeries receiving management adherent to current guidelines and standard of care procedures. Atrial arrhythmia incidence after surgical procedure will be collected using in-hospital telemetry or serial Electrocardiogram (ECG) from all patients in their respective cohorts. Cardiac surgery type, duration and any intraoperative complications will be recorded. Other clinical and relevant demographical data will be collected at admission and throughout patients' hospital stay. 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.
研究者
入排标准
入选标准
- •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).
排除标准
- •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)
结局指标
主要结局
Incidence of atrial arrhythmia in patients after cardiac surgery
时间窗: 2 weeks
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.
次要结局
- Incidence of sudden cardiac arrest(2 weeks)
- Incidence of shock(2 weeks)
- Incidence of systemic or pulmonary embolism(2 weeks)
- Rate of in-hospital mortality(2 weeks)
- Incidence of acute respiratory failure(2 weeks)
- Hospital and Intensive Care Unit (ICU) length of stay (LOS)(2 weeks)
- Incidence of stroke(2 weeks)
- Incidence of infection post surgery(2 weeks)
- Hospitalization costs to the patient(2 weeks)