An observational study in Lung Cancer and Atrial Fibrillation, sponsored by University of Manitoba. Status unknown at 1 site in Canada. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2020-04-03.
Sponsored by University of Manitoba · Observational
Atrial fibrillation (AF) is a common and serious complication after lung resection. The incidence is likely underestimated, and risk may persist after leaving hospital. Recent development of simple wearable patch ECG devices may provide sensitive detection of AF in the extended postoperative period. Specific biomarkers may allow us to predict which patients are at risk of developing postoperative AF.
Postoperative atrial fibrillation (POAF) is a serious complication that can occur after thoracic surgery. A substantial proportion of AF is clinically silent, detectable only by ECG monitoring. Despite the lack of symptoms, it is still associated with increased risk of stroke, and may partly explain the risk of postoperative mortality after discharge from hospital.
No studies have been completed investigating the occurrence of AF in an extended period of monitoring following non-cardiac surgery, including thoracic surgery. In the limited literature on extended ECG monitoring following cardiac surgery, recurrent AF affected 24% of patients after discharge from hospital, and only 30% had symptoms. In total, 49% of patients in these studies had POAF up to two weeks after surgery.
Detection of POAF increases with more intensive monitoring. Therefore investigators believe that the incidence of POAF is underestimated, and extended monitoring using a patch ECG device will allow increased detection of clinically evident and silent POAF.
Investigators will place CardioSTAT (Icentia Inc, QC, Canada) patch ECG devices on patients immediately after thoracic surgery. They will be worn for two weeks continuously, following which they are returned by mail to the manufacturer. These devices are simple to apply and can be worn even in the shower and while exercising. Technologist interpretation is provided by the manufacturer, and will be corroborated by our study cardiologist.
Patients will also wear the patch ECG for 14 days prior to surgery. This will provide information on how many patients have silent AF at baseline, and will make it possible to determine whether AF after surgery is new or is an exacerbation of a pre-existing but unknown condition.
A total of 100 patients will allow a 95% confidence interval of 21-40% around an assumed true POAF incidence of 30%. The lower limit exceeds conventional estimates of POAF following thoracic surgery, and would provide strong support for our hypothesis.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 100 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients who are undergoing elective thoracic surgery for non septic indications, both benign and malignant.
Exclusion Criteria:
Absolute incidence of postoperative atrial fibrillation
Detected by device
Time frame: 14 days postop
Rate of accrual relative to the number of eligible patients per month
Determined by proportion of patients enrolled
Time frame: 6-month recruitment period
90-day mortality
Determined by telephone follow-up and check of medical records
Time frame: 90 days following surgery
Incidence of stroke
Clinical diagnosis based on treatment
Time frame: 90 days following surgery
Atrial fibrillation burden
Number of atrial fibrillation events per patient developing POAF
Time frame: 14 days postop
Atrial fibrillation burden
Duration of atrial fibrillation events per patient developing POAF
Time frame: 14 days postop
Incidence of preoperative subclinical atrial fibrillation
Number of patients with subclinical AF prior to surgery
Time frame: 14 days within 6 weeks prior to surgery
Adherence to study protocol: Number of patients completing full 14-day use of CardioSTAT device
Number of patients completing full 14-day use of CardioSTAT device
Time frame: 14 days preop, 14 days postop
Adherence to study protocol: Number of days CardioSTAT device worn per patient
Number of days CardioSTAT device worn per patient
Time frame: 14 days postop
Adherence to study protocol: Number of patients completing symptom journal
Number of patients completing symptom journal
Time frame: 14 days postop
Plan to share: No
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University of Manitoba