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

NCT04325269 | Unknown

• 1 other identifier: HS23428
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Atrial Fibrillation

Keywords

Atrial Fibrillation; Symptomatic Atrial Fibrillation; Asymptomatic Atrial Fibrillation; Lung Resection; Ambulatory Cardiac Monitor; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Absolute incidence of postoperative atrial fibrillation

  Detected by device

  14 days postop

Secondary Outcomes (9)

• Rate of accrual relative to the number of eligible patients per month

  6-month recruitment period

• 90-day mortality

  90 days following surgery

• Incidence of stroke

  90 days following surgery

• Atrial fibrillation burden

  14 days postop

• Atrial fibrillation burden

  14 days postop

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are undergoing elective thoracic surgery for non septic indications, both benign and malignant.

You may qualify if:

• Adult patients, age ≥ 55 years at time of surgery, undergoing thoracic surgery with general anesthesia
• Co-enrolment in the NT-proBNP biomarker monitoring study

You may not qualify if:

• Patients with a prior history of documented AF
• Patients with an implanted pacemaker or defibrillator
• Patients currently taking anti-arrhythmic medication other than ß- blockers, calcium channel blockers or digoxin
• Patients undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies)
• 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
• Patients with known allergy to adhesives

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

Location

Related Publications (4)

• 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.

  PMID: 22236222 BACKGROUND

• 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-Cote 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.

  PMID: 31358597 BACKGROUND

• 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. 2016 Jul;50(1):44-51. doi: 10.1093/ejcts/ezv486. Epub 2016 Feb 4.

  PMID: 26850266 RESULT

• 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 Rhythm. 2014 Jul;11(7):1156-62. doi: 10.1016/j.hrthm.2014.03.040. Epub 2014 Mar 21.

  PMID: 24657803 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sadeesh Srinathan, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sadeesh Srinathan, MD

CONTACT

2047873791; ssrinathan@hsc.mb.ca

Emma Poole

CONTACT

2047875625

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 27, 2020
• Study Start: April 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)