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Lung CancerNCT04325269

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

An observational study of Lung Cancer and Atrial Fibrillation, run by University of Manitoba at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Lung Cancer, Atrial Fibrillation
How many people
100 participants
Where
1 siteCanada
Study dates
1 Apr 2020to 1 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sadeesh Srinathan, MD contact

2047873791

ssrinathan@hsc.mb.ca

Emma Poole contact

2047875625

Canada1 site

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A1R9

Other trials in Canada

About this study

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.

Read the 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.

Keywords
Atrial Fibrillation, Symptomatic Atrial Fibrillation, Asymptomatic Atrial Fibrillation, Lung Resection, Ambulatory Cardiac Monitor, Thoracic Surgery
Medical subject headings
Lung Neoplasms, Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute incidence of postoperative atrial fibrillation

    Detected by device

    Measured: 14 days postop

Secondary outcomes (9)

  1. Rate of accrual relative to the number of eligible patients per month

    Determined by proportion of patients enrolled

    Measured: 6-month recruitment period

  2. 90-day mortality

    Determined by telephone follow-up and check of medical records

    Measured: 90 days following surgery

  3. Incidence of stroke

    Clinical diagnosis based on treatment

    Measured: 90 days following surgery

  4. Atrial fibrillation burden

    Number of atrial fibrillation events per patient developing POAF

    Measured: 14 days postop

  5. Atrial fibrillation burden

    Duration of atrial fibrillation events per patient developing POAF

    Measured: 14 days postop

  6. Incidence of preoperative subclinical atrial fibrillation

    Number of patients with subclinical AF prior to surgery

    Measured: 14 days within 6 weeks prior to surgery

  7. 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

    Measured: 14 days preop, 14 days postop

  8. Adherence to study protocol: Number of days CardioSTAT device worn per patient

    Number of days CardioSTAT device worn per patient

    Measured: 14 days postop

  9. Adherence to study protocol: Number of patients completing symptom journal

    Number of patients completing symptom journal

    Measured: 14 days postop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020
  2. Study start1 Apr 2020 (estimated)
  3. Primary completion1 Feb 2021 (estimated)
  4. Study completion1 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04325269
Sponsor's protocol ID
HS23428
Status last verified
Feb 2020
First submitted
5 Mar 2020
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 22236222

  • 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.

    PubMed 31358597

  • 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.

    PubMed 26850266

  • 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.

    PubMed 24657803

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Atrial Fibrillation, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sadeesh Srinathan, MD (2047873791, ssrinathan@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute incidence of postoperative atrial fibrillation (time frame: 14 days postop). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04325269, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

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