Diagnostic Yield of an Ambulatory Patch Monitor in Emergency Department Syncope Patients Unexplained After Emergency Department Evaluation: A Pilot Study (PATCH-ED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Lothian
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia
研究概览
简要总结
Syncope is a common Emergency Department (ED) presentation but the underlying diagnosis is not apparent in 60% of patients after assessment and serious adverse event rate is 7% at one month with most having acute cardiovascular events, also more likely to be unexplained after ED assessment. Many cardiovascular events are due to arrhythmia, difficult for clinicians to diagnose, as examination and Electrocardiogram (ECG) findings may both be normal and symptoms have resolved by the time the patient gets to the ED. Currently establishing a cardiac arrhythmia as the cause of syncope rests on correlating the arrhythmia with symptoms using monitoring devices such as Holter but these all have significant drawbacks. The clinical challenge in the ED is therefore to identify the moderate and high-risk patients and refer them for further investigation and monitoring if appropriate. The logistics of arranging follow up within a timely period of the patient's ED visit is often problematic for a variety of reasons including availability of timely specialty outpatient appointments, a lack of consensus of the specialty to whom the syncope patient should be referred (cardiology, medicine, neurology, general practice) and availability of Holter and other monitoring devices. For this reason most high and medium risk patients are admitted to hospital.
Previous syncope clinical decision rules have not been well adopted due to their lack of sensitivity and specificity probably due to the varied and heterogeneous nature of potentially serious causes. However, the majority of patients with syncope have no serious underlying pathology and do not require hospitalisation. Rather than continued attempts at risk stratification of outcome based on presentation, more research is required into how we can better improve diagnosis and therefore treatment in order to provide improved patient benefit. We believe that ambulatory patch monitoring will allow better and earlier arrhythmia detection and plan to assess the ability of a 14-day ambulatory patch to detect serious arrhythmic outcomes at 90 days.
详细描述
There are around 650,000 ED syncope presentations a year in the United Kingdom (UK). Serious underlying conditions can present with syncope and one-month serious adverse outcome is around 7% with 50% being cardiovascular. The treating ED clinician is not always able to rule out serious pathology as the patient is commonly fully recovered on arrival in the ED, despite the underlying cause being potentially life threatening should it recur again. Whilst most patients do not have a serious underlying cause and therefore do not require hospitalisation, the concern of the ED clinician about missing a serious underlying cause (especially cardiovascular ones) means that 50% of syncope patients are admitted to hospital.
Despite research identifying high-risk demographic, historical and examination variables, clinical decision rules have not been well adopted due to their lack of sensitivity and specificity probably due to the varied and heterogeneous nature of potentially serious causes. Rather than continued attempts at risk stratification of outcome based on presentation, more research is required into how we can better improve diagnosis and therefore treatment in order to provide improved patient benefit.
Cardiovascular causes of syncope fall into two main categories, arrhythmia (e.g. ventricular tachycardia (VT), 2nd degree Mobitz II, 3rd degree atrioventricular block or symptomatic bradycardia) and structural (e.g. aortic stenosis). It is arrhythmia that is most difficult for the ED clinician to diagnose in the ED as examination and presenting Electrocardiogram ECG may both be normal. It is for this reason that arrhythmia makes up a large number of subsequent serious outcomes in syncope patients whose syncopal cause is unexplained after ED assessment.
The current main method for establishing a cardiac arrhythmia as the cause of syncope rests on the correlation of the arrhythmia with symptoms (which will have resolved by the time the patient gets to the ED). The clinical challenge in the ED is therefore to identify the moderate and high-risk patients and refer them for further investigation and monitoring if appropriate. The logistics of arranging follow up within a timely period of the patient's ED visit is often problematic for a variety of reasons including availability of timely specialty outpatient appointments, a lack of consensus of the specialty to whom the syncope patient should be referred (cardiology, medicine, neurology, general practice) and availability of Holter and other monitoring devices. For this reason most high and medium risk patients are admitted to hospital.
The investigation of cardiac arrhythmias is usually initiated with the Holter monitor which uses a continuous recording over a 24 or 48-hour period. The Holter allows detection of baseline rhythm, arrhythmia and conduction abnormalities. Holters however are bulky and inconvenient for the patient to wear, the transmission of data is not patient dependent and non-compliance with both device use and maintaining a written symptom log, limits its diagnostic utility. The lack of extended monitoring reduces diagnostic yield to typically less than 20%. Bass reported a diagnostic yield of 15% with 24-hour Holter monitoring that did not increase even if the device was applied for 72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16 years or over presenting within 6 hours of an episode of syncope and whose syncope remains unexplained after ED assessment. Syncope will be defined as a transient loss of consciousness (TLOC) with inability to maintain postural tone and immediate complete spontaneous recovery without medical intervention (to preexisting mental status and neurologic function)
排除标准
- •Obvious underlying cause after ED assessment,
- •Alcohol or illicit drugs as presumptive cause of TLOC [24],
- •Epileptic seizure as presumptive cause of TLOC (seizure activity with a >15 min witness reported post-ictal phase) [24],
- •Stroke ⁄ transient ischemic attack as presumptive cause of TLOC [24],
- •Head trauma followed by TLOC [24],
- •Hypoglycemia as presumptive cause of TLOC [24],
- •No consent i.e. patient lacking capacity,
- •Previous recruitment into the study,
- •Patient in custody or prison.
- •Obvious underlying causes will be defined as:
- •Clinical history of vasovagal syncope i.e. pre-syncope symptoms and low-risk patient according to current ESC guidelines [14],
- •Arrhythmia on ED ECG thought to have caused syncope,
- •Arrhythmia on pre-hospital ECG causing syncope,
- •Pulmonary embolism (PE) diagnosed on Computed Tomography Pulmonary Angiography (CTPA; or equivalent e.g. symptoms of PE plus positive leg ultrasound scan/ventilation-perfusion scan/echo),
- •Postural hypotension (postural drop >20 mmHg in ED with symptoms during test and suggestive history),
- •Myocardial Infarction [25],
- •CT brain or clinical signs/symptoms in ED showing cerebrovascular accident or subarachnoid haemorrhage,
- •Evidence of haemorrhage in ED thought to have caused syncope,
- •Other obvious cause of syncope apparent in ED.
结局指标
主要结局
Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia
时间窗: 90 days
Significant arrhythmia will be defined as: * Non-symptomatic ventricular tachycardia \< 30 seconds, * Symptomatic sinus bradycardia \< 60 beats/minute (but \>40 or less than 30 seconds), * Asymptomatic sinus bradycardia \< 40 beats/minute, * Sick sinus syndrome with alternating sinus bradycardia and tachycardia, * Sinus pause \> 3 seconds (but less than 6 seconds), * Symptomatic Mobitz type I atrioventricular heart block, * Junctional/idioventricular rhythm, * Symptomatic supraventricular tachycardia with rate \> 100/minute, * Symptomatic atrial flutter/fibrillation with ventricular rate \>100/min, * Symptomatic atrial flutter/fibrillation with ventricular rate \<60/min Arrhythmias will also be defined as symptomatic (i.e. concurrent light-headedness/dizziness, syncope/presyncope with arrhythmia) or asymptomatic.
次要结局
- Number of Participants With Arrhythmia(90 days)
- Number of Participants Who Agreed or Strongly Agreed That the Patch Monitor Was Easy to Use.(90 days)
- Median Device Wear Time(14 days)
- Number of Participants With All Cause Serious Outcome(90 days)
- Median Time to Detection of Significant Symptomatic Arrhythmia(90 days)
- Number of Participants With Significant Arrhythmia Requiring Referral.(90 days)