Skip to main content
OpenTrials
Completed

NCT Number: NCT03221777

Atrial Fibrillation Occurring Transiently With Stress (AFOTS)

Rationale Atrial fibrillation (AF) often occurs transiently in the setting of an acute stressor (e.g.

medical illness or surgery). Uncertainty exists as to whether AF Occurring Transiently with Stress (AFOTS) is secondary to a reversible precipitant and is benign, or is a first presentation of paroxysmal AF and associated with a risk of stroke. AFOTS is a common occurrence (>40% in some intensive care settings), but there is a lack of evidence to guide its management and guidelines have called for further research in this area. Retrospective data suggest that many patients with AFOTS (>50%) will experience recurrent AF. These estimates were obtained without using sensitive methods for AF detection, which raises the possibility that the true rate of recurrent AF is much higher. As the rate of recurrent AF increases, it becomes increasingly likely that AFOTS is just the first detection of typical "clinical" AF.

Objective To use a sensitive strategy to determine the rate of recurrent AF among patients who experienced AFOTS following i) non-cardiac surgery OR ii) medical illness, compared to matched controls.

Methods Two multi-centre, 138-patient, observational cohorts. AFOTS patients will have new AF, documented by 12-Lead ECG or surface monitoring, during hospitalization for non- cardiac surgery (Cohort 1) or medical illness (Cohort 2).

Controls will be patients without a history of AF who are matched for age (within 5 years), sex and exposure to stressor. Participants will wear a 14-day ECG monitor at 1 and 6 months after discharge. The endpoint is detection of AF.

Impact

If the incidence of AF after AFOTS is >80%, clinicians could be advised to treat AFOTS like "clinical" AF and initiate anticoagulation according to guidelines. Otherwise, a strategy of surveillance for AF would be advised.

Hypothesis

1. Patients who experience AFOTS will have a higher future incidence of AF and of stroke compared to patients exposed to a similar stressor but who did not develop AF. 2. The risk of recurrent AF after AFOTS will be sufficiently high (> 80%) to warrant routine initiation of long-term OAC in all cases.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation New Onset

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cases will be patients without a history of AF who experience new AFOTS during hospital admission for non-cardiac surgery (non-cardiac surgery study) OR medical illness (medical illness study) Controls will be patients who were exposed to a similar stressor but did not develop AF (matched for age within 5 years, sex and stressor).

All participants will have a CHA2DS2-VaSc score >1 for men, >2 for women.

Exclusion criteria

  • Documented prior history of AF.
  • Patients whose rhythm is AF at the time of discharge from hospital
  • Patients unsuitable for study follow-up because the patient:
  • is unreliable concerning the follow-up schedule
  • cannot be contacted by telephone
  • has a life expectancy less than one year
  • Unwilling or unable to participate in the study
  • Presence of an implanted pacemaker or defibrillator.
  • Documented significant allergy to ECG electrode adhesive.
  • Residence in a chronic care facility
  • Diagnosed with Ischemic Stroke or Systemic embolism on admission
  • Primary cardiac admitting diagnosis (i.e. myocardial infarction, heart failure, pericarditis, arrhythmia)
  • Patients with Stage V Chronic Kidney Disease

Treatment and study plan

14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

Diagnostic Test

The ZIO XT Patch (http://www.irhythmtech.com/zio-solution/zio-patch/) is an ultra-portable wearable adhesive patch monitor that provides continuous single-lead ECG recording for up to 14 days. It has been cleared by the FDA for arrhythmia detection and is in current clinical use in the U.S.[87]. It will be used in this study under an investigational testing authorization by Health Canada. The ZIO XT Patch is a single-use device worn over the left pectoral region with a skin adhesive (Figure 4). Its small, lightweight, water-resistant, patch-based design has advantages for patients compared with traditional ECG screening methods (e.g. Holter, event loop recorders, mobile outpatient telemetry systems), which are all more cumbersome and require detachable wired leads, two or more removable skin contact electrodes, plus separate recording units (+/- smartphone attachment).

Primary outcomes

  1. Atrial Fibrillation >/=30 s

    Time frame: 1 year

Secondary outcomes

  1. Time to Atrial Fibrillation

    Time frame: 1 year

    Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: time to first detection of AF >30 s.

  2. Daily and total AF burden

    Time frame: 1 year

    Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: daily and total AF burden.

  3. Average duration per AF episode

    Time frame: 1 year

    Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: average duration per AF episode

  4. Other durations of Atrial Fibrillation

    Time frame: 1 year

    Among AFOTS patients, occurence of any AF episode lasting ≥30 seconds, ≥30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature).( within 12 months post-enrolment)

  5. Atrial Fibrillation at 1 and 6 months

    Time frame: 1 and 6 months

    Detection of the primary outcome at 1 and 6 months post enrolment.

  6. Other clinical outcomes

    Time frame: 1 year

    Incidence of Clinical outcome events within 12 months post-enrolment (death, stroke, bleeding, embolism and hospitalization for heart failure or myocardial infarction), physician visits, hospitalizations and medication prescriptions.

  7. OAC Use

    Time frame: 1 year

    Oral anticoagulant therapy use

  8. Cost-effectiveness

    Time frame: 1 year

    Cost-effectiveness (cost per life year saved)

  9. Cost-utility

    Time frame: 1 year

    cost-utility (cost per quality adjusted life year (QALY) gained) of AF screening

  10. Patient adherence

    Time frame: 1 year

    Patient adherence with the monitoring devices (defined as the average number of monitoring days completed and reasons for non-adherence)

  11. Patient satisfaction

    Time frame: 1 year

    patient satisfaction with the monitoring devices (as measured by user satisfaction surveys),

  12. Sensitivity and Specificity

    Time frame: 1 year

    Estimated sensitivity, specificity of non-patch ECG monitoring(i.e. monitoring done outside of the study protocol), with ZioXT ECG patch monitor as the gold standard

  13. Other arrhythmias

    Time frame: 1 year

    Incidence of Detection of other potentially clinically important non-AF arrhythmias: atrial tachycardia, pause >3 seconds, high-grade atrioventricular block (Mobitz type II or third-degree AV block), ventricular tachycardia, polymorphic ventricular tachycardia/ventricular fibrillation. ( within 12 months post-enrolment)

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Canadian Cardiovascular Society
  • Canadian Stroke Prevention Intervention Network

Registry information

Official study title

Atrial Fibrillation Occurring Transiently With Stress (AFOTS): Understanding the Risks of Recurrent AF. Study in Non-cardiac Surgery and in Medical Illness Patients.

Acronym: AFOTS

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2017
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.