Atrial Fibrillation Occurring Transiently With Stress (AFOTS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

281 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03552588

Atrial Fibrillation New Onset

COMPLETED

Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial

NCT05841056

Atrial Fibrillation New Onset

RECRUITING PHASE3

Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)

NCT00000556

Arrhythmia Atrial Fibrillation Cardiovascular Diseases +1 more

COMPLETED PHASE3

Atrial Fibrillation and Congestive Heart Failure Trial

NCT00597077

Atrial Fibrillation Congestive Heart Failure

COMPLETED PHASE4

Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring

NCT04038944

New Onset Atrial Fibrillation

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation New Onset

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

Intervention Type 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).

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

14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

Intervention Type 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 - 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

14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

Intervention Type 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).

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

14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No