Atrial Fibrillation New OnsetNCT03552588
High Sensitivity Estimate of the Incidence of Atrial Fibrillation Occurring Transiently With Stress (AFOTS Incidence Study)
An observational study of Atrial Fibrillation New Onset, run by Population Health Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- Continuous Electrocardiogram
- How many people
- 249 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2019to 1 Feb 2020
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive patients admitted to the medical or surgical ICU
Who may be able to join
- Adults, admitted to the ICU, without a history of AF who are either:
- 65 years of age or older
- 50 years of age or older and have at least one CHADS2 Risk Factor
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- Continuous Electrocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous ElectrocardiogramDiagnostic test
A high-sensitivity, 14-day continuous ECG monitor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AF lasting > 30 seconds
Measured: Within 14 days of admission
Secondary outcomes (5)
Incidence of AF captured clinically
Measured: Within 14 days of admission
Incidence of AF lasting > 5 minutes
Measured: Within 14 days of admission
Incidence of AF lasting > 1 hour
Measured: Within 14 days of admission
Incidence of AF lasting > 6 hours
Measured: Within 14 days of admission
Incidence of AF lasting > 24 hours
Measured: Within 14 days of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Jun 2019
- Primary completion30 Oct 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552588
- Sponsor's protocol ID
- 2018-4740
- Status last verified
- Nov 2023
- First submitted
- 29 May 2018
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 31629099McIntyre 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Sensitivity Estimate of the Incidence of Atrial Fibrillation Occurring Transiently With Stress (AFOTS Incidence Study)
- ClinicalTrials.gov ID
- NCT03552588
- Acronym / sponsor ID
- 2018-4740
- Conditions
- Atrial Fibrillation New Onset
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted to the medical or surgical ICU
Key inclusion criteria (3 listed)
- Adults, admitted to the ICU, without a history of AF who are either:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous ElectrocardiogramA high-sensitivity, 14-day continuous ECG monitor. | Diagnostic test | – |
Primary outcome
Incidence of AF lasting > 30 seconds
Time frame: Within 14 days of admission
5 secondary outcomes
Incidence of AF captured clinically
Time frame: Within 14 days of admission
Incidence of AF lasting > 5 minutes
Time frame: Within 14 days of admission
Incidence of AF lasting > 1 hour
Time frame: Within 14 days of admission
Incidence of AF lasting > 6 hours
Time frame: Within 14 days of admission
Incidence of AF lasting > 24 hours
Time frame: Within 14 days of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 31629099McIntyre 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.
- Results publication: PubMed 33458680McIntyre 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation New Onset, run by Population Health Research Institute 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AF lasting > 30 seconds (time frame: Within 14 days of admission). 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 NCT03552588, which also lists 2 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 8 Nov 2023.