Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- First episode of atrial fibrillation
研究概览
简要总结
Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The investigators want to detect those people so they can receive appropriate anticoagulation treatment. The patients will get a comprehensive workup including ecg, echocardiography and blood tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 65 years
- •arterial hypertension (at least dual treatment)
- •diabetes mellitus (oral antidiabetics or insulin)
排除标准
- •known atrial fibrillation
- •ischaemic heart disease
- •Current anticoagulation treatment
- •Ejection fraction <45 %
- •significant valvular heart disease
- •previous stroke/transient ischemic attack
- •peripheral arterial disease
- •end stage renal disease
- •thyreotoxicosis
研究组 & 干预措施
Holter monitoring
Screening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring
干预措施: Conventional Holter monitoring (Other)
Implantable loop recorder
Screening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder
干预措施: Implantable loop recorder (Device)
结局指标
主要结局
First episode of atrial fibrillation
时间窗: 1 year
次要结局
- Correlation between echocardiographic parameters and incidence of atrial fibrillation(1 year)
研究者
Axel Brandes
Associate Professor
Odense University Hospital