Trial Outcomes & Findings for Diagnostic Yield of an Ambulatory Patch Monitor in Unexplained Emergency Department Syncope: A Pilot Study (PATCH-ED) (NCT NCT02683174)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

86 participants

Primary outcome timeframe

90 days

Results posted on

2019-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Single Study Arm All enrolled patients will be fitted with a novel ambulatory patch (ZIO®Patch), which continuously records heartbeats for up to 14 days. Brain natriuretic peptide (BNP) and hs-troponin I at 0 and 3 hours post ED attendance Novel ambulatory patch (ZIO® XT Patch): All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch) BNP and hs-troponin I at 0 and 3 hours post ED attendance: All patients will have quantification of hs-troponin I (ARCHITECTSTAT high-sensitivity troponin I assay) and BNP (ALERE TRIAGE point-of-care BNP test; ALERE, San Diego, USA; www.alere.co.uk) at 0 and 3 hours post ED attendance.
Overall Study STARTED	86
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Study Arm n=86 Participants All enrolled patients will be fitted with a novel ambulatory patch (ZIO®Patch), which continuously records heartbeats for up to 14 days. Brain natriuretic peptide (BNP) and hs-troponin I at 0 and 3 hours post ED attendance Novel ambulatory patch (ZIO® XT Patch): All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch) BNP and hs-troponin I at 0 and 3 hours post ED attendance: All patients will have quantification of hs-troponin I (ARCHITECTSTAT high-sensitivity troponin I assay) and BNP (ALERE TRIAGE point-of-care BNP test; ALERE, San Diego, USA; www.alere.co.uk) at 0 and 3 hours post ED attendance.
Sex: Female, Male Male	46 Participants n=86 Participants
Age, Continuous	62.8 years STANDARD_DEVIATION 19.5 • n=86 Participants
Sex: Female, Male Female	40 Participants n=86 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Study Group n=86 Participants Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days.
Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia	9 Participants

SECONDARY outcome

Timeframe: 90 days

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

Outcome measures

Outcome measures
Measure	Study Group n=86 Participants Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days.
Median Time to Detection of Significant Symptomatic Arrhythmia	19 days Interval 4.0 to 30.0

SECONDARY outcome

Timeframe: 90 days

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

Outcome measures

Outcome measures
Measure	Study Group n=86 Participants Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days.
Number of Participants With Arrhythmia Yes	24 Participants
Number of Participants With Arrhythmia No	62 Participants

SECONDARY outcome

Timeframe: 90 days

Population: All study participants who returned the participant patch satisfaction postal questionnaire (n=47).

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

Outcome measures

Outcome measures
Measure	Study Group n=47 Participants Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days.
Number of Participants Who Agreed or Strongly Agreed That the Patch Monitor Was Easy to Use. Yes	43 Participants
Number of Participants Who Agreed or Strongly Agreed That the Patch Monitor Was Easy to Use. No	4 Participants

SECONDARY outcome

Timeframe: 14 days

Patch compliance described by median device wear time

Outcome measures

Outcome measures
Measure	Study Group n=86 Participants Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days.
Median Device Wear Time	13.6 days Interval 11.8 to 14.0

SECONDARY outcome

Timeframe: 90 days

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

Outcome measures

Outcome measures
Measure	Study Group n=86 Participants Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days.
Number of Participants With Significant Arrhythmia Requiring Referral.	12 Participants

SECONDARY outcome

Timeframe: 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, * Initiation of anti-arrhythmia medical therapy, * Ventricular assist device

Outcome measures

Outcome measures
Measure	Study Group n=86 Participants Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days.
Number of Participants With All Cause Serious Outcome	26 Participants

Adverse Events

Study Arm

Serious events: 26 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Study Arm n=86 participants at risk All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch)
Cardiac disorders Significant arrhythmia	27.9% 24/86 • Number of events 24 • 90 days Patients were followed up at 90 days after presentation through hospital and primary care electronic patient record (EPR) systems. Patients who had left the NHS Lothian area after 1 month were contacted by telephone.
Cardiac disorders Permanent pacemaker or defibrillator placement	4.7% 4/86 • Number of events 4 • 90 days Patients were followed up at 90 days after presentation through hospital and primary care electronic patient record (EPR) systems. Patients who had left the NHS Lothian area after 1 month were contacted by telephone.
Cardiac disorders Coronary artery bypass graft or coronary artery stent	2.3% 2/86 • Number of events 2 • 90 days Patients were followed up at 90 days after presentation through hospital and primary care electronic patient record (EPR) systems. Patients who had left the NHS Lothian area after 1 month were contacted by telephone.
Cardiac disorders Significant structural heart disease	1.2% 1/86 • Number of events 1 • 90 days Patients were followed up at 90 days after presentation through hospital and primary care electronic patient record (EPR) systems. Patients who had left the NHS Lothian area after 1 month were contacted by telephone.
Cardiac disorders Positive electrophysiology study findings	1.2% 1/86 • Number of events 1 • 90 days Patients were followed up at 90 days after presentation through hospital and primary care electronic patient record (EPR) systems. Patients who had left the NHS Lothian area after 1 month were contacted by telephone.
Cardiac disorders Initiation of antiarrhythmia medical therapy	2.3% 2/86 • Number of events 2 • 90 days Patients were followed up at 90 days after presentation through hospital and primary care electronic patient record (EPR) systems. Patients who had left the NHS Lothian area after 1 month were contacted by telephone.
Cardiac disorders Major adverse cardiac events [MACE]	30.2% 26/86 • Number of events 26 • 90 days Patients were followed up at 90 days after presentation through hospital and primary care electronic patient record (EPR) systems. Patients who had left the NHS Lothian area after 1 month were contacted by telephone.

Other adverse events

Adverse event data not reported

Additional Information

Dr Matt Reed

NHS Lothian

Phone: +44 131 242 1448

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place