Atrial Fibrillation Occurring Transiently With Stress (AFOTS): Understanding the Risks of Recurrent AF. Study in Non-cardiac Surgery and in Medical Illness Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 3
- 主要终点
- Atrial Fibrillation >/=30 s
研究概览
简要总结
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
- 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.
- The risk of recurrent AF after AFOTS will be sufficiently high (> 80%) to warrant routine initiation of long-term OAC in all cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Atrial Fibrillation >/=30 s
时间窗: 1 year
次要结局
- 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)
- Time to Atrial Fibrillation(1 year)
- Other clinical outcomes(1 year)
- Patient satisfaction(1 year)
- Daily and total AF burden(1 year)
- Cost-effectiveness(1 year)
- Cost-utility(1 year)
- OAC Use(1 year)
- Sensitivity and Specificity(1 year)
- Patient adherence(1 year)
- Other arrhythmias(1 year)
研究者
William McIntyre
Research Fellow
Population Health Research Institute