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AFOTS - Medical Illness Cases for Atrial Fibrillation (AFOTS Trial)

N/A
Waitlist Available
Led By Jeff Healey
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Atrial Fibrillation at 1 and 6 months
Average duration per AF episode
Cost-effectiveness
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Non-cardiac Surgery ControlsExperimental Treatment1 Intervention
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
Group II: Medical Illness ControlsExperimental Treatment1 Intervention
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
Group III: AFOTS - Non-cardiac surgery CasesExperimental Treatment1 Intervention
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
Group IV: AFOTS - Medical Illness CasesExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)
2017
N/A
~290

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
161 Previous Clinical Trials
711,853 Total Patients Enrolled
33 Trials studying Atrial Fibrillation
54,841 Patients Enrolled for Atrial Fibrillation
Canadian Cardiovascular SocietyOTHER
6 Previous Clinical Trials
455 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
254 Patients Enrolled for Atrial Fibrillation
Canadian Stroke Prevention Intervention NetworkOTHER
3 Previous Clinical Trials
2,173 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
2,173 Patients Enrolled for Atrial Fibrillation
~33 spots leftby Sep 2025