N/A
N=86
Diagnostic Yield of an Ambulatory Patch Monitor in Unexplained Emergency Department Syncope: A Pilot Study (PATCH-ED)
Syncope
Bottom Line
View on ClinicalTrials.gov: NCT02683174 ↗Enrolled (actual)
86
Serious AEs
30.2%
Results posted
Dec 2019
Primary outcome: Primary: Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Novel ambulatory patch (ZIO® XT Patch) (Device); BNP and hs-troponin I at 0 and 3 hours post ED attendance (Biological)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- NHS Lothian
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia |
9 | — |
| SECONDARY Median Time to Detection of Significant Symptomatic Arrhythmia |
19 | — |
| SECONDARY Number of Participants With Arrhythmia |
24; 62 | — |
| SECONDARY Number of Participants Who Agreed or Strongly Agreed That the Patch Monitor Was Easy to Use. |
43; 4 | — |
| SECONDARY Median Device Wear Time |
13.6 | — |
| SECONDARY Number of Participants With Significant Arrhythmia Requiring Referral. |
12 | — |
| SECONDARY Number of Participants With All Cause Serious Outcome |
26 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02683174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.