Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Atrial Fibrillation Occurring Transiently With Stress (AFOTS) (AFOTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03221777
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Canadian Cardiovascular Society
Canadian Stroke Prevention Intervention Network
Information provided by (Responsible Party):
William McIntyre, Population Health Research Institute

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.

Condition or disease Intervention/treatment
Atrial Fibrillation New Onset Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 276 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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).

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)
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 - 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)
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).

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)
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).




Primary Outcome Measures :
  1. Atrial Fibrillation >/=30 s [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time to Atrial Fibrillation [ Time Frame: 1 year ]
    Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: time to first detection of AF >30 s.

  2. Daily and total AF burden [ Time Frame: 1 year ]
    Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: daily and total AF burden.

  3. Average duration per AF episode [ Time Frame: 1 year ]
    Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: average duration per AF episode

  4. Other durations of Atrial Fibrillation [ Time Frame: 1 year ]
    Among AFOTS patients, occurence of any AF episode lasting ≥30 seconds, ≥30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature).( within 12 months post-enrolment)

  5. Atrial Fibrillation at 1 and 6 months [ Time Frame: 1 and 6 months ]
    Detection of the primary outcome at 1 and 6 months post enrolment.

  6. Other clinical outcomes [ Time Frame: 1 year ]
    Incidence of Clinical outcome events within 12 months post-enrolment (death, stroke, bleeding, embolism and hospitalization for heart failure or myocardial infarction), physician visits, hospitalizations and medication prescriptions.

  7. OAC Use [ Time Frame: 1 year ]
    Oral anticoagulant therapy use

  8. Cost-effectiveness [ Time Frame: 1 year ]
    Cost-effectiveness (cost per life year saved)

  9. Cost-utility [ Time Frame: 1 year ]
    cost-utility (cost per quality adjusted life year (QALY) gained) of AF screening

  10. Patient adherence [ Time Frame: 1 year ]
    Patient adherence with the monitoring devices (defined as the average number of monitoring days completed and reasons for non-adherence)

  11. Patient satisfaction [ Time Frame: 1 year ]
    patient satisfaction with the monitoring devices (as measured by user satisfaction surveys),

  12. Sensitivity and Specificity [ Time Frame: 1 year ]
    Estimated sensitivity, specificity of non-patch ECG monitoring(i.e. monitoring done outside of the study protocol), with ZioXT ECG patch monitor as the gold standard

  13. Other arrhythmias [ Time Frame: 1 year ]
    Incidence of Detection of other potentially clinically important non-AF arrhythmias: atrial tachycardia, pause >3 seconds, high-grade atrioventricular block (Mobitz type II or third-degree AV block), ventricular tachycardia, polymorphic ventricular tachycardia/ventricular fibrillation. ( within 12 months post-enrolment)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

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): NCT03221777


Contacts
Layout table for location contacts
Contact: Elham Ramezani 905-521-2100 ext 40398 afots@phri.ca
Contact: Heather Beresh 905-527-4322 ext 40351 Heather.Beresh@phri.ca

Locations
Layout table for location information
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada
Contact: William McIntyre, MD       william.mcintyre@phri.ca   
Principal Investigator: Jeff Healey, MD         
Juravinski Hospital Recruiting
Hamilton, Ontario, Canada
St. Joseph's Health Centre Recruiting
Hamilton, Ontario, Canada
Sponsors and Collaborators
Population Health Research Institute
Canadian Cardiovascular Society
Canadian Stroke Prevention Intervention Network
Investigators
Layout table for investigator information
Principal Investigator: Jeff Healey Population Health Research Institute
Layout table for additonal information
Responsible Party: William McIntyre, Research Fellow, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03221777    
Other Study ID Numbers: AFOTS
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes