Clinical trial NCT03221777: Atrial Fibrillation Occurring Transiently With Stress (AFOTS)
Official title: Atrial Fibrillation Occurring Transiently With Stress (AFOTS): Understanding the Risks of Recurrent AF. Study in Non-cardiac Surgery and in Medical Illness Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation New Onset
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Cardiovascular Society
name: Canadian Stroke Prevention Intervention Network
First posted: 2017-07-19
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted for non-cardiac surgery OR medical Illness, who develop new Atrial Fibrillation Occurring Transiently With Stress (AFOTS) during hospital admission (case group), OR who are exposed to the same stressor, but did not develop AF (control group).

All patients will be candidates for OAC therapy as per the Canadian Cardiovascular Society (CCS) AF algorithm \[12\]. Patients with a history of AF will be excluded from the study.

Brief summary: 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.


Eligibility criteria: 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:

1. Documented prior history of AF.
2. Patients whose rhythm is AF at the time of discharge from hospital
3. Patients unsuitable for study follow-up because the patient:

   1. is unreliable concerning the follow-up schedule
   2. cannot be contacted by telephone
   3. has a life expectancy less than one year
4. Unwilling or unable to participate in the study
5. Presence of an implanted pacemaker or defibrillator.
6. Documented significant allergy to ECG electrode adhesive.
7. Residence in a chronic care facility
8. Diagnosed with Ischemic Stroke or Systemic embolism on admission
9. Primary cardiac admitting diagnosis (i.e. myocardial infarction, heart failure, pericarditis, arrhythmia)
10. Patients with Stage V Chronic Kidney Disease

Primary outcomes:
measure: Atrial Fibrillation >/=30 s
timeFrame: 1 year
Secondary outcomes:
measure: Time to Atrial Fibrillation
timeFrame: 1 year
measure: Daily and total AF burden
timeFrame: 1 year
measure: Average duration per AF episode
timeFrame: 1 year
measure: Other durations of Atrial Fibrillation
timeFrame: 1 year
measure: Atrial Fibrillation at 1 and 6 months
timeFrame: 1 and 6 months
measure: Other clinical outcomes
timeFrame: 1 year
measure: OAC Use
timeFrame: 1 year
measure: Cost-effectiveness
timeFrame: 1 year
measure: Cost-utility
timeFrame: 1 year
measure: Patient adherence
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
measure: Sensitivity and Specificity
timeFrame: 1 year
measure: Other arrhythmias
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Jeff Healey
role: PRINCIPAL_INVESTIGATOR
References:
citation: McIntyre WF, Vadakken ME, Connolly SJ, Mendoza PA, Lengyel AP, Rai AS, Latendresse NR, Grinvalds AJ, Ramasundarahettige C, Acosta JG, Um KJ, Roberts JD, Conen D, Wong JA, Devereaux PJ, Belley-Cote EP, Whitlock RP, Healey JS. Atrial Fibrillation Recurrence in Patients With Transient New-Onset Atrial Fibrillation Detected During Hospitalization for Noncardiac Surgery or Medical Illness : A Matched Cohort Study. Ann Intern Med. 2023 Oct;176(10):1299-1307. doi: 10.7326/M23-1411. Epub 2023 Oct 3.