Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Monthly rate of patient accrual
研究概览
简要总结
Lung resections for pulmonary malignancies offer the best chance of survival for patients, but these procedures carry a significant burden of post-operative morbidity and mortality. Patients are particularly at high risk for post-operative atrial fibrillation (a condition involving irregular heart rhythm). Atrial fibrillation with symptoms can increase the risk of stroke - a blockage in a major blood vessel in the brain, which can potentially result in a disability or even death. The objective of this study is to establish the feasibility of using ambulatory heart rate monitoring to determine the total incidence of atrial fibrillation in the peri-operative period before and after anatomic lung resection for malignancies. The study will also investigate the correlation between atrial fibrillation and rates of stroke and other adverse events, as well as serve to identify the patients that are at a higher risk of developing atrial fibrillation.
详细描述
Novel literature suggests that atrial fibrillation that is asymptomatic may just be as problematic as atrial fibrillation that presents itself with symptoms. The objective of the study is to establish the feasibility of tracking the total incidence of atrial fibrillation in the peri-operative period, including both symptomatic and asymptomatic events, using an ambulatory heart monitor. Additionally, the study aims to estimate the overall incidence of peri- and post-operative atrial fibrillation. These will be accomplished through usage of iRhythm ZIO XT, a small pebble shaped device that will be adhered to the patient's chest for 14 days before and after surgery, to measure how often atrial fibrillation occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be at least 18 years of age and competent to consent
- •Patients must be diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy
- •Patients must have one of: Male gender, age greater than 65, hypertension, obesity, and recent tobacco use within the past year
- •Patients must be booked for pneumonectomy, lobectomy or anatomical segmentectomy resection.
排除标准
- •Patients undergoing emergent lung resection
- •Patients undergoing lung resection for non-oncologic indications (lung biopsy, bullectomy)
- •Patients with an existing neurostimulator
- •Patients with pre-existing cardiac disease, defined as:
- •Patients with atrioventricular blockage of any degree or sick sinus syndrome;
- •Patients with known previous atrial fibrillation or flutter lasting more than 1 month;
- •Patients with any persistent diagnosed preoperative arrhythmia
- •Patients with implanted external defibrillators or pacemakers
- •Patients with known adhesive allergies
- •Inability to comply with or understand ambulatory monitoring.
结局指标
主要结局
Monthly rate of patient accrual
时间窗: Ongoing from date of study initiation through to sample size completion, estimated to be 12 months
Proportion of patients who are determined to be eligible for study relative to the number of patients actually enrolled and consented for participation in the study. This will help to inform the willingness of patients to participate in this study
Patient adherence to monitoring device use-Wear time
时间窗: 28 day time period around lung resection
Patient adherence to the device attachment requirements as stated in the study protocol, defined as the device remaining in place for at least 90% of the expected 28 day patch period (14 days before surgery and 14 days after) to determine feasibility of the study protocol in clinical context and patient tolerability. This will be measured by the iRhythm ZIO XT patch output.
Number of patients who withdraw from study protocol
时间窗: 28 day time period around lung resection
Number of patients who choose to withdraw from the study, defined as those who fail to complete the 14-day baseline monitoring period before surgery, decline to wear the device post-operatively, or drop out partway through the 14-day post-operative monitoring period. This will be measured by ongoing discussion with the patient and will help to determine the feasibility of the study protocol in clinical context and patient tolerability.
Patient adherence to monitoring device use-Logging of symptomatic events
时间窗: 28 day time period around lung resection
Patient adherence to the symptomatic atrial fibrillation event logging task as stated in the study protocol, defined as the successful manual triggering of the device by the patient to note at least 80% of symptomatic events over the expected 28 day patch period (14 days before surgery and 14 days after) to determine feasibility of the study protocol in clinical context and patient tolerability. This will be measured by the iRhythm ZIO XT patch output.
次要结局
- Baseline incidence of asymptomatic atrial fibrillation before lung resection(Measured from 2 weeks preceding lung resection up to the day of procedure)
- Total event rate for asymptomatic atrial fibrillation(Comparison of the two intervals of 14 days preceding and 14 days following lung resection)
- Impact of resection intensity (larger versus smaller resection size) on the development of any atrial fibrillation events(Measured from post-operative day 1 to 14 days following lung resection)
- The number of post-operative atrial fibrillation events(Measured from post-operative day 1 to 14 days following lung resection)
- Rate of other non- atrial fibrillation arrhythmia(Measured from post-operative day 1 to 14 days following lung resection)
- Impact of use of minimally invasive surgery on the development of any atrial fibrillation events(Measured from post-operative day 1 to 14 days following lung resection)
- The number of any post-operative recurrent atrial fibrillation events within 14 days of lung resection(Difference in event rates between the 14 day baseline period before surgery and the 14 day period after surgery)
- Measurement of the difference of rates of stroke in event-free patients and those with atrial fibrillation(Interval from the date of surgery to up to 90 days after surgery)
- Measurement of the difference of 90 day mortality in event-free patients and those with atrial fibrillation(Interval from the date of surgery to up to 90 days after surgery)