- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325269
Continuous Ambulatory ECG Monitoring for Detection of Postoperative Atrial Fibrillation Following Thoracic Surgery
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sadeesh Srinathan, MD
- Phone Number: 2047873791
- Email: ssrinathan@hsc.mb.ca
Study Contact Backup
- Name: Emma Poole
- Phone Number: 2047875625
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3A1R9
- Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients, age ≥ 55 years at time of surgery, undergoing thoracic surgery with general anesthesia
- Co-enrolment in the NT-proBNP biomarker monitoring study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute incidence of postoperative atrial fibrillation
Time Frame: 14 days postop
|
Detected by device
|
14 days postop
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of accrual relative to the number of eligible patients per month
Time Frame: 6-month recruitment period
|
Determined by proportion of patients enrolled
|
6-month recruitment period
|
90-day mortality
Time Frame: 90 days following surgery
|
Determined by telephone follow-up and check of medical records
|
90 days following surgery
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Incidence of stroke
Time Frame: 90 days following surgery
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Clinical diagnosis based on treatment
|
90 days following surgery
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Atrial fibrillation burden
Time Frame: 14 days postop
|
Number of atrial fibrillation events per patient developing POAF
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14 days postop
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Atrial fibrillation burden
Time Frame: 14 days postop
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Duration of atrial fibrillation events per patient developing POAF
|
14 days postop
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Incidence of preoperative subclinical atrial fibrillation
Time Frame: 14 days within 6 weeks prior to surgery
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Number of patients with subclinical AF prior to surgery
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14 days within 6 weeks prior to surgery
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Adherence to study protocol: Number of patients completing full 14-day use of CardioSTAT device
Time Frame: 14 days preop, 14 days postop
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Number of patients completing full 14-day use of CardioSTAT device
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14 days preop, 14 days postop
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Adherence to study protocol: Number of days CardioSTAT device worn per patient
Time Frame: 14 days postop
|
Number of days CardioSTAT device worn per patient
|
14 days postop
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Adherence to study protocol: Number of patients completing symptom journal
Time Frame: 14 days postop
|
Number of patients completing symptom journal
|
14 days postop
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sadeesh Srinathan, MD, University of Manitoba
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS23428
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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