NCT02683174: PATCH-ED

Diagnostic Yield of an Ambulatory Patch Monitor in Unexplained Emergency Department Syncope: A Pilot Study (PATCH-ED)

Completed NA Results posted Last updated 3 December 2019

What this trial tests

NA trial testing Novel ambulatory patch (ZIO® XT Patch) in Syncope in 86 participants. Completed in 13 September 2017.

Timeline

1 November 2015

Primary endpoint
13 June 2017

13 September 2017

Quick facts

Lead sponsor	NHS Lothian
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	86
Start date	1 November 2015
Primary completion	13 June 2017
Estimated completion	13 September 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

• Novel ambulatory patch (ZIO® XT Patch)
• BNP and hs-troponin I at 0 and 3 hours post ED attendance — full drug profile →

Conditions studied

• Syncope — all drugs for Syncope →

Sponsor

NHS Lothian — full company profile →

Who can join

16 and older, any sex, with Syncope. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia Primary · 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 \>10

Group	Value	95% CI
Study Group	9

Median Time to Detection of Significant Symptomatic Arrhythmia Secondary · 90 days

Median time to detection of significant symptomatic arrhythmia by ambulatory patch monitor

Group	Value	95% CI
Study Group	19	4 – 30

Number of Participants With Arrhythmia Secondary · 90 days

Prevalence of arrhythmia including serious significant arrhythmia, significant arrhythmia and symptomatic arrhythmia in ED syncope patients unexplained after ED evaluation.

Group	Value	95% CI
Single Study Arm	24
Single Study Arm	62

Number of Participants Who Agreed or Strongly Agreed That the Patch Monitor Was Easy to Use. Secondary · 90 days

Number of participants who agreed or strongly agreed that the patch monitor was easy to use. Patient patch satisfaction (postal questionnaire).

Group	Value	95% CI
Single Study Arm	43
Single Study Arm	4

Median Device Wear Time Secondary · 14 days

Patch compliance described by median device wear time

Group	Value	95% CI
Single Study Arm	13.6	11.8 – 14.0

Number of Participants With Significant Arrhythmia Requiring Referral. Secondary · 90 days

Number of participants with significant underlying arrhythmic pathology on ambulatory patch monitoring requiring referral.

Group	Value	95% CI
Single Study Arm	12

Number of Participants With All Cause Serious Outcome Secondary · 90 days

All cause serious outcome will be a composite of: * All cause death, * Major adverse cardiac events \[MACE\] * Myocardial infarction \[25\], * Significant arrhythmia \[25\], * Significant Structural Heart Disease \[23\], * Positive Electrophysiology Study Findings \[25\] * Permanent pacemaker or defibrillator placement, * Coronary artery bypass graft or coronary artery stent, * Cardiac valve surgery, * Elective cardioversion in the absence of objective evidence that tachyarrhythmia is responsible for the syncope, * Balloon-pump insertion, * Heart transplant, * Initiatio

Group	Value	95% CI
Single Study Arm	26

Adverse events — posted to ClinicalTrials.gov

Time frame: 90 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Study Arm

Serious: 26/86 (30%)

Deaths: 1/86

Serious adverse events (7 terms)

Reaction	System	Study Arm
Major adverse cardiac events [MACE]	Cardiac disorders	—
Significant arrhythmia	Cardiac disorders	—
Permanent pacemaker or defibrillator placement	Cardiac disorders	—
Coronary artery bypass graft or coronary artery stent	Cardiac disorders	—
Initiation of antiarrhythmia medical therapy	Cardiac disorders	—
Significant structural heart disease	Cardiac disorders	—
Positive electrophysiology study findings	Cardiac disorders	—

Most-reported serious reactions: Major adverse cardiac events [MACE], Significant arrhythmia, Permanent pacemaker or defibrillator placement, Coronary artery bypass graft or coronary artery stent, Initiation of antiarrhythmia medical therapy, Significant structural heart disease, Positive electrophysiology study findings.

Data from ClinicalTrials.gov NCT02683174 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Diagnostic yield of an ambulatory patch monitor in patients with unexplained syncope after initial evaluation in the emergency department: the PATCH-ED study.
   Reed MJ, Grubb NR, Lang CC, Gray AJ, et al · · 2018 · cited 20× · PMID 29921622 · DOI 10.1136/emermed-2018-207570