Atrial Fibrillation Occurring Transiently With Stress (AFOTS)

NCT03221777 | Completed FDA Device

• 1 other identifier: AFOTS
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 3

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. 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. 2.The risk of recurrent AF after AFOTS will be sufficiently high (\> 80%) to warrant routine initiation of long-term OAC in all cases.

Conditions

Atrial Fibrillation New Onset

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation >/=30 s

  1 year

Secondary Outcomes (13)

• Time to Atrial Fibrillation

  1 year

• Daily and total AF burden

  1 year

• Average duration per AF episode

  1 year

• Other durations of Atrial Fibrillation

  1 year

• Atrial Fibrillation at 1 and 6 months

  1 and 6 months

Study Arms (4)

AFOTS - Medical Illness Cases

Patients who have AF detected for the first time in the setting of an acute non-cardiovascular medical (i.e. non-surgical ). 14 day patch ECG monitor at 1 month and 6 months after hospital discharge

Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

Medical Illness Controls

Patients without a history of AF who are hospitalized for an acute non-cardiovascular medical (i.e. non-surgical) and do not have AF detected. 14 day patch ECG monitor at 1 month and 6 months after hospital discharge

Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

AFOTS - Non-cardiac surgery Cases

Patients who have AF detected for the first time following non-cardiac surgery. 14 day patch ECG monitor at 1 month and 6 months after hospital discharge

Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

Non-cardiac Surgery Controls

Patients without a history of AF who are hospitalized after non-cardiac surgery and do not have AF detected. 14 day patch ECG monitor at 1 month and 6 months after hospital discharge

Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

Interventions

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).

AFOTS - Medical Illness Cases; AFOTS - Non-cardiac surgery Cases; Medical Illness Controls; Non-cardiac Surgery Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead
• Canadian Cardiovascular Society: collaborator
• Canadian Stroke Prevention Intervention Network: collaborator

Study Sites (3)

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Juravinski Hospital

Hamilton, Ontario, Canada

Location

St. Joseph's Health Centre

Hamilton, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 37782930 RESULT

Study Officials

• Jeff Healey

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 19, 2017
• Study Start: March 1, 2017
• Primary Completion: August 31, 2022
• Study Completion: November 30, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

CA (3)