Use of Implantable Loop Recorders as a Primary Investigation of Infrequent Undiagnosed ArrhythmIa Symptoms in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- The primary endpoint of the study is the proportion of patients achieving a definite diagnosis in each of the two groups at the end of one year
研究概览
简要总结
Heart rhythm abnormalities underlie one of the common presenting complaints to the A&E and out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having symptoms, it is very difficult to determine the cause of the palpitations. The conventional approach is to refer these patients from the emergency departments to the Cardiology outpatients where they undergo repeated short term rhythm monitoring hoping to record the rhythm underlying the patient's complaint. Unfortunately, this often yields no results thus delaying definitive treatment and incurring extra costs of repeated investigations and A&E presentations. This study aims to compare the ability of the conventional approach to establish a definite diagnosis compared to that of an early invasive monitoring approach with a small implantable device that records the heart rhythm at all time for up to 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age 18 years or older
- •Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness)
- •Terminates before presentation to hospital
- •Episodes occur at a frequency of less than once every two weeks
- •Never previously caught on ECG or ambulatory monitoring
- •Normal resting ECG
排除标准
- •Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR >1.6, ongoing infection, sepsis or fever, etc.
- •Palpitations suggestive of extrasystoles (single missed or dropped beats)
- •Known or suspected severe valvular or myocardial heart disease
- •An audible heart murmur
- •Any abnormality on the surface ECG
- •Thyrotoxicosis
- •Patients who refuse an ILR when offered will not be included in either limb of the study
结局指标
主要结局
The primary endpoint of the study is the proportion of patients achieving a definite diagnosis in each of the two groups at the end of one year
时间窗: 1 year
次要结局
- The time taken from randomisation in the A&E to making the diagnosis (if any) in each group(1 Year)
- The cost of achieving a diagnosis in each group(1 Year)