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

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ClinicalTrials.gov Identifier: NCT03552588
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Richard Whitlock, Population Health Research Institute

Brief 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.


Condition or disease Intervention/treatment
Atrial Fibrillation New Onset Diagnostic Test: Continuous Electrocardiogram

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Sensitivity Estimate of the Incidence of Atrial Fibrillation Occurring Transiently With Stress (AFOTS Incidence Study)
Estimated Study Start Date : July 3, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Continuous Electrocardiogram
    A high-sensitivity, 14-day continuous ECG monitor.


Primary Outcome Measures :
  1. Incidence of AF lasting > 30 seconds [ Time Frame: Within 14 days of admission ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients admitted to the medical or surgical ICU
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552588


Contacts
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Contact: William F McIntyre, MD 905-521-2100 ext 40414 william.mcintyre@phri.ca
Contact: Emilie P Belley-Cote, MD 905-521-2100 emilie.belley-cote@phri.ca

Sponsors and Collaborators
Population Health Research Institute
Hamilton Health Sciences Corporation

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Responsible Party: Richard Whitlock, Principal Investigator, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03552588     History of Changes
Other Study ID Numbers: 2018-4740
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes