Continuous Ambulatory ECG Monitoring for Detection of Postoperative Atrial Fibrillation Following Thoracic Surgery

Lung Cancer Clinical Trial

Official title:

Continuous Ambulatory ECG Monitoring for Detection of Postoperative Atrial Fibrillation Following Thoracic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04325269
• Other study ID #: HS23428
• Status: Not yet recruiting
• Start date: April 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2020
• Source: University of Manitoba
• Contact: Sadeesh Srinathan, MD
• Phone: 2047873791
• Email: ssrinathan[@]hsc.mb.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients, age = 55 years at time of surgery, undergoing thoracic surgery with general anesthesia

2. Co-enrolment in the NT-proBNP biomarker monitoring study

Exclusion Criteria:

1. Patients with a prior history of documented AF

2. Patients with an implanted pacemaker or defibrillator

3. Patients currently taking anti-arrhythmic medication other than ß- blockers, calcium channel blockers or digoxin

4. Patients undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies)

5. Patients who are unable or unwilling to wear the CardioSTAT device as per manufacturer's guidelines, or who are unable/unwilling to return the device via mail to Icentia for procession and analysis

6. Patients with known allergy to adhesives

Related Conditions & MeSH terms

• Atrial Fibrillation
• Lung Cancer

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Bidar E, Maesen B, Nieman F, Verheule S, Schotten U, Maessen JG. A prospective randomized controlled trial on the incidence and predictors of late-phase postoperative atrial fibrillation up to 30 days and the preventive value of biatrial pacing. Heart Rhy — View Citation

Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575. Erratum in: N Engl J Med. 2016 Mar 10;374(10):998. — View Citation

Lowres N, Mulcahy G, Gallagher R, Ben Freedman S, Marshman D, Kirkness A, Orchard J, Neubeck L. Self-monitoring for atrial fibrillation recurrence in the discharge period post-cardiac surgery using an iPhone electrocardiogram. Eur J Cardiothorac Surg. 201 — View Citation

Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators, Spence J, LeManach Y, Chan MTV, Wang CY, Sigamani A, Xavier D, Pearse R, Alonso-Coello P, Garutti I, Srinathan SK, Duceppe E, Walsh M, Borges FK, Malaga G, Abraham V, Faruqui A, Berwanger O, Biccard BM, Villar JC, Sessler DI, Kurz A, Chow CK, Polanczyk CA, Szczeklik W, Ackland G, X GA, Jacka M, Guyatt GH, Sapsford RJ, Williams C, Cortes OL, Coriat P, Patel A, Tiboni M, Belley-Côté EP, Yang S, Heels-Ansdell D, McGillion M, Parlow S, Patel M, Pettit S, Yusuf S, Devereaux PJ. Association between complications and death within 30 days after noncardiac surgery. CMAJ. 2019 Jul 29;191(30):E830-E837. doi: 10.1503/cmaj.190221. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute incidence of postoperative atrial fibrillation	Detected by device	14 days postop
Secondary	Rate of accrual relative to the number of eligible patients per month	Determined by proportion of patients enrolled	6-month recruitment period
Secondary	90-day mortality	Determined by telephone follow-up and check of medical records	90 days following surgery
Secondary	Incidence of stroke	Clinical diagnosis based on treatment	90 days following surgery
Secondary	Atrial fibrillation burden	Number of atrial fibrillation events per patient developing POAF	14 days postop
Secondary	Atrial fibrillation burden	Duration of atrial fibrillation events per patient developing POAF	14 days postop
Secondary	Incidence of preoperative subclinical atrial fibrillation	Number of patients with subclinical AF prior to surgery	14 days within 6 weeks prior to surgery
Secondary	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	14 days preop, 14 days postop
Secondary	Adherence to study protocol: Number of days CardioSTAT device worn per patient	Number of days CardioSTAT device worn per patient	14 days postop
Secondary	Adherence to study protocol: Number of patients completing symptom journal	Number of patients completing symptom journal	14 days postop