Clinical trial NCT02547168: Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection
Official title: Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Atrial Fibrillation
Stroke
Keywords: Atrial Fibrillation
Symptomatic Atrial Fibrillation
Asymptomatic Atrial Fibrillation
Lung Resection
Ambulatory Cardiac Monitor
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster Surgical Associates
First posted: 2015-09-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Monthly rate of patient accrual
timeFrame: Ongoing from date of study initiation through to sample size completion, estimated to be 12 months
measure: Patient adherence to monitoring device use-Wear time
timeFrame: 28 day time period around lung resection
measure: Patient adherence to monitoring device use-Logging of symptomatic events
timeFrame: 28 day time period around lung resection
measure: Number of patients who withdraw from study protocol
timeFrame: 28 day time period around lung resection
Secondary outcomes:
measure: Baseline incidence of asymptomatic atrial fibrillation before lung resection
timeFrame: Measured from 2 weeks preceding lung resection up to the day of procedure
measure: The number of post-operative atrial fibrillation events
timeFrame: Measured from post-operative day 1 to 14 days following lung resection
measure: The number of any post-operative recurrent atrial fibrillation events within 14 days of lung resection
timeFrame: Difference in event rates between the 14 day baseline period before surgery and the 14 day period after surgery
measure: Total event rate for asymptomatic atrial fibrillation
timeFrame: Comparison of the two intervals of 14 days preceding and 14 days following lung resection
measure: Rate of other non- atrial fibrillation arrhythmia
timeFrame: Measured from post-operative day 1 to 14 days following lung resection
measure: Impact of resection intensity (larger versus smaller resection size) on the development of any atrial fibrillation events
timeFrame: Measured from post-operative day 1 to 14 days following lung resection
measure: Impact of use of minimally invasive surgery on the development of any atrial fibrillation events
timeFrame: Measured from post-operative day 1 to 14 days following lung resection
measure: Measurement of the difference of 90 day mortality in event-free patients and those with atrial fibrillation
timeFrame: Interval from the date of surgery to up to 90 days after surgery
measure: Measurement of the difference of rates of stroke in event-free patients and those with atrial fibrillation
timeFrame: Interval from the date of surgery to up to 90 days after surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Yaron Shargall, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References: