Long-term Recurrence Rates of Atrial Fibrillation Following New-onset Atrial Fibrillation During ICU Admission
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Recurrence rates of atrial-fibrillation following new-onset atrial-fibrillation during intensive care unit
研究概览
简要总结
The Primary Objective of the study is to establish the One-year recurrence rates of atrial fibrillation (AF) following new-onset atrial fibrillation during intensive care unit (ICU) admission.
The Secondary Objective is a composite of death from cardiovascular causes, stroke (either ischemic or hemorrhagic), or hospitalization with worsening of heart failure or recurrent AF.
The prevalence and recurrence rates of AF will be divided into sub-groups based on primary ICU admission diagnosis.
All-cause mortality.
详细描述
Patients will be screened for atrial fibrillation during hospitalization in the intensive care unit and will be followed until discharge. Once discharged home or to a rehabilitation center, they will be invited to a routine follow-up clinic at RMC cardiology institute 4-6 weeks after hospital discharge. During the clinic visit, patients will be recruited to the study follow-up plan.
The follow-up plan will consist of 3 clinical visits at 4-6 weeks, 6-months and 1 -year after discharge.
The follow-up program will include a comprehensive screening for symptomatic and asymptomatic atrial fibrillation events as following:
Patients will be provided with a home cellular-digital 12-lead ECG transmitter. They will be instructed to conduct routine weekly transmission in order to record asymptomatic events as well as to transmit at any time they suspect an event/feel symptoms (palpitations). Home routine testing will be initiated and guided by a telephone call from a medical monitoring center. A blinded, independent, on-call medical professional team will analyze the received ECG.
A 48-hour Holter ECG will be performed at 6 months and 12 months after ICU discharge
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
- •Admitted to ICU over 24 hours
- •Diagnosed with new-onset atrial fibrillation
- •The patient survived the index hospitalization and was discharged home/ to a rehabilitation center.
排除标准
- •Previously documented atrial fibrillation
结局指标
主要结局
Recurrence rates of atrial-fibrillation following new-onset atrial-fibrillation during intensive care unit
时间窗: One-year
A positive ECG or Holter test for atrial fibrillation will be regarded as recurrence.
次要结局
- Major adverse cardiovascular events(3-years)
- Recurrence rates of atrial-fibrillation(3-years)
- All-cause mortality(3-years)
研究者
Katia Orvin
Katia Orvin M.D - director of cardiac intensive care unit, Rabin Medical Center
Rabin Medical Center