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CompletedNCT03552588Updated Nov 8, 2023

High Sensitivity Estimate of the Incidence of Atrial Fibrillation Occurring Transiently With Stress (AFOTS Incidence Study)

An observational study in Atrial Fibrillation New Onset, sponsored by Population Health Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-08.

Sponsored by Population Health Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
249
Ages
18 Years and older
Sex
All
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Study summary

BACKGROUND: Atrial fibrillation (AF) is the most common serious heart rhythm disorder and is associated with a 4 to 5-fold increase in the risk of ischemic stroke. AF is often detected for the first time while a patient is hospitalized for an acute medical illness or after surgery. In these settings, AF can be transient and frequently asymptomatic; detection often occurs during prolonged periods of continuous ECG monitoring in an intensive care unit (ICU).

Atrial Fibrillation Occurring Transiently with Stress (AFOTS) describes the manifestation of AF in the acute care setting as the only evidence of AF, for which the incidence and appropriate management are uncertain. AFOTS may be directly and uniquely due to a reversible precipitant and thus unlikely to recur after this precipitant is removed, thereby having minimal impact on the patient's long-term prognosis. Alternatively, AFOTS may be the first detection of a chronic condition that is already present but undiagnosed - facilitated by inpatient continuous ECG monitoring.

Previous published studies have provided a wide range of estimates for the incidence of AFOTS in the ICU population (3-44%). Differences in estimates may be explained by the methods used to detect AFOTS in these studies.

A precise estimate of the incidence of AFOTS is required in order to understand its long-term significance. The present study is designed to generate an accurate estimate of the incidence of AFOTS.

PRIMARY OBJECTIVE: To determine the incidence of AF, lasting 30 seconds or more, in hospitalized patients in the ICU over the age of 65 and without a prior history of AF. This will be achieved with a high-sensitivity, 14-day continuous ECG monitor.

IMPORTANCE: AFOTS may be common, and may respond to established therapies for stroke prevention. However, varying methodologies in existing studies have resulted in wide variations around its incidence. The systematic protocol employed in this study will generate a precise and accurate estimate of the incidence of AFOTS.

There is uncertainty around the incidence, recurrence and management of AFOTS. The results of this study will be integrated with those from the other studies in the AFOTS research program. Together, they will inform the monitoring of hospitalized patients for AFOTS, the outpatient rhythm monitoring for recurrences of AF and ultimately stroke prevention.

STUDY DESIGN: This is a prospective descriptive epidemiologic study. It is a component study of the AFOTS Research Program.

POPULATION: Consecutive participants aged 65 years and older without a history of AF, who are admitted to the ICU at Hamilton General or Juravinski hospital for treatment of medical illness or for recovery from noncardiac surgery.

OUTCOMES: The primary outcome will be the proportion of patients with AF lasting 30 seconds or more, as detected by the patch monitor. Secondary outcomes will include: the proportion of patients who have AF documented by the clinical team; the proportion of patients with AF lasting 5 minutes or more, 1 hour or more, 6 hours or more and 24 hours or more; the burden of AF, defined as time spent in AF per 24 hours and the proportion of AF episodes that occur with an average heart rate of 1-40 bpm, 41-60 bpm, 61-80 bpm, 81-100bpm, 101-120 bpm, and 121-140 bpm and > 140 bpm.

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Conditions studied

  • Atrial Fibrillation New Onset

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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 249 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Population Health Research Institute is the lead sponsor of 114 studies on the registry; 27 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Consecutive patients admitted to the medical or surgical ICU

Inclusion criteria

  • Adults, admitted to the ICU, without a history of AF who are either:

    1. 65 years of age or older
    2. 50 years of age or older and have at least one CHADS2 Risk Factor

Exclusion criteria

Exclusion Criteria:

  • Patients who are palliative or not expected to survive for at least 12 hours.
  • Patients for whom it is judged that placement of the ECG monitor would preclude administration of necessary care.
  • Patients with known adhesive allergies.
  • Patients with primary cardiovascular diagnoses (i.e. confirmed myocardial infarction, heart failure, arrhythmia) or cardiac surgery.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
249 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testContinuous Electrocardiogram

    A high-sensitivity, 14-day continuous ECG monitor.

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What researchers measure

Primary outcomes

  1. Incidence of AF lasting > 30 seconds

    Time frame: Within 14 days of admission

Secondary outcomes

  1. Incidence of AF captured clinically

    Time frame: Within 14 days of admission

  2. Incidence of AF lasting > 5 minutes

    Time frame: Within 14 days of admission

  3. Incidence of AF lasting > 1 hour

    Time frame: Within 14 days of admission

  4. Incidence of AF lasting > 6 hours

    Time frame: Within 14 days of admission

  5. Incidence of AF lasting > 24 hours

    Time frame: Within 14 days of admission

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Study locations

1 site
  • Hamilton Health Sciences
    Hamilton, Canada
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References and documents

Publications

  • McIntyre WF, Lengyel AP, Healey JS, Vadakken ME, Rai AS, Rochwerg B, Bhatnagar A, Deif B, Spence J, Bangdiwala SI, Belley-Cote EP, Whitlock RP. Design and rationale of the atrial fibrillation occurring transiently with stress (AFOTS) incidence study. J Electrocardiol. 2019 Nov-Dec;57:95-99. doi: 10.1016/j.jelectrocard.2019.09.014. Epub 2019 Sep 6. PubMed 31629099 ↗
  • McIntyre WF, Belley-Cote EP, Vadakken ME, Rai AS, Lengyel AP, Rochwerg B, Bhatnagar AK, Deif B, Um KJ, Spence J, Connolly SJ, Bangdiwala SI, Rao-Melacini P, Healey JS, Whitlock RP. High-Sensitivity Estimate of the Incidence of New-Onset Atrial Fibrillation in Critically Ill Patients. Crit Care Explor. 2021 Jan 8;3(1):e0311. doi: 10.1097/CCE.0000000000000311. eCollection 2021 Jan. PubMed 33458680 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03552588
Lead sponsor
Population Health Research Institute
Collaborators
Hamilton Health Sciences Corporation
Responsible party
Sponsor
First posted
Jun 12, 2018
Start date
Jun 1, 2019
Primary completion
Oct 30, 2019
Completion
Feb 1, 2020
Last update
Nov 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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