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

• ClinicalTrials.gov Identifier: NCT02683174
• Recruitment Status: Completed
• First Posted: February 17, 2016
• Results First Posted: December 3, 2019
• Last Update Posted: December 3, 2019
• Sponsor: NHS Lothian
• Information provided by (Responsible Party): NHS Lothian

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Syncope
• Interventions: Device: Novel ambulatory patch (ZIO® XT Patch); Biological: BNP and hs-troponin I at 0 and 3 hours post ED attendance
• Enrollment: 86

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Single Study Arm
Arm/Group Description	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.
Period Title: Overall Study
Started	86
Completed	86
Not Completed	0

Baseline Characteristics

Arm/Group Title		Single Study Arm
Arm/Group Description		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 Number of Baseline Participants		86
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	86 participants
		62.8 (19.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	86 participants
	Female	40 46.5%
	Male	46 53.5%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.

Outcome Measures

1. Primary Outcome

Title	Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia
Description	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.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Group
Arm/Group Description:	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.
Overall Number of Participants Analyzed	86
Measure Type: Count of Participants; Unit of Measure: Participants
	9 10.5%

2. Secondary Outcome

Title	Median Time to Detection of Significant Symptomatic Arrhythmia
Description	Median time to detection of significant symptomatic arrhythmia by ambulatory patch monitor
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Group
Arm/Group Description:	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.
Overall Number of Participants Analyzed	86
Median (Inter-Quartile Range); Unit of Measure: days
	19; (4 to 30)

3. Secondary Outcome

Title	Number of Participants With Arrhythmia
Description	Prevalence of arrhythmia including serious significant arrhythmia, significant arrhythmia and symptomatic arrhythmia in ED syncope patients unexplained after ED evaluation.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Study Arm
Arm/Group Description:	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 Number of Participants Analyzed	86
Measure Type: Count of Participants; Unit of Measure: Participants
Yes	24 27.9%
No	62 72.1%

4. Secondary Outcome

Title	Number of Participants Who Agreed or Strongly Agreed That the Patch Monitor Was Easy to Use.
Description	Number of participants who agreed or strongly agreed that the patch monitor was easy to use. Patient patch satisfaction (postal questionnaire).
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Single Study Arm
Arm/Group Description:	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 Number of Participants Analyzed	47
Measure Type: Count of Participants; Unit of Measure: Participants
Yes	43 91.5%
No	4 8.5%

5. Secondary Outcome

Title	Median Device Wear Time
Description	Patch compliance described by median device wear time
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Study Arm
Arm/Group Description:	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 Number of Participants Analyzed	86
Median (Inter-Quartile Range); Unit of Measure: days
	13.6; (11.8 to 14.0)

6. Secondary Outcome

Title	Number of Participants With Significant Arrhythmia Requiring Referral.
Description	Number of participants with significant underlying arrhythmic pathology on ambulatory patch monitoring requiring referral.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Study Arm
Arm/Group Description:	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 Number of Participants Analyzed	86
Measure Type: Count of Participants; Unit of Measure: Participants
	12 14.0%

7. Secondary Outcome

Title	Number of Participants With All Cause Serious Outcome
Description	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
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Study Arm
Arm/Group Description:	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 Number of Participants Analyzed	86
Measure Type: Count of Participants; Unit of Measure: Participants
	26 30.2%

Adverse Events

Time Frame	90 days
Adverse Event Reporting Description	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.
Arm/Group Title	Study Arm
Arm/Group Description	All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch)
All-Cause Mortality
	Study Arm
	Affected / at Risk (%)
Total	1/86 (1.16%)
Serious Adverse Events
	Study Arm
	Affected / at Risk (%)	# Events
Total	26/86 (30.23%)
Cardiac disorders
Significant arrhythmia †	24/86 (27.91%)	24
Permanent pacemaker or defibrillator placement †	4/86 (4.65%)	4
Coronary artery bypass graft or coronary artery stent †	2/86 (2.33%)	2
Significant structural heart disease †	1/86 (1.16%)	1
Positive electrophysiology study findings †	1/86 (1.16%)	1
Initiation of antiarrhythmia medical therapy †	2/86 (2.33%)	2
Major adverse cardiac events [MACE] †	26/86 (30.23%)	26
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Study Arm
	Affected / at Risk (%)	# Events
Total	0/86 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr Matt Reed
• Organization: NHS Lothian
• Phone: +44 131 242 1448
• EMail: Matthew.Reed@nhslothian.scot.nhs.uk

Publications:

Reed MJ, Newby DE, Coull AJ, Prescott RJ, Jacques KG, Gray AJ. The ROSE (risk stratification of syncope in the emergency department) study. J Am Coll Cardiol. 2010 Feb 23;55(8):713-21. doi: 10.1016/j.jacc.2009.09.049.

Reed MJ, Henderson SS, Newby DE, Gray AJ. One-year prognosis after syncope and the failure of the ROSE decision instrument to predict one-year adverse events. Ann Emerg Med. 2011 Sep;58(3):250-6. doi: 10.1016/j.annemergmed.2010.12.021. Epub 2011 Feb 2.

Martin TP, Hanusa BH, Kapoor WN. Risk stratification of patients with syncope. Ann Emerg Med. 1997 Apr;29(4):459-66. doi: 10.1016/s0196-0644(97)70217-8.

Oh JH, Hanusa BH, Kapoor WN. Do symptoms predict cardiac arrhythmias and mortality in patients with syncope? Arch Intern Med. 1999 Feb 22;159(4):375-80. doi: 10.1001/archinte.159.4.375.

Colivicchi F, Ammirati F, Melina D, Guido V, Imperoli G, Santini M; OESIL (Osservatorio Epidemiologico sulla Sincope nel Lazio) Study Investigators. Development and prospective validation of a risk stratification system for patients with syncope in the emergency department: the OESIL risk score. Eur Heart J. 2003 May;24(9):811-9. doi: 10.1016/s0195-668x(02)00827-8.

Sarasin FP, Hanusa BH, Perneger T, Louis-Simonet M, Rajeswaran A, Kapoor WN. A risk score to predict arrhythmias in patients with unexplained syncope. Acad Emerg Med. 2003 Dec;10(12):1312-7. doi: 10.1111/j.1553-2712.2003.tb00003.x.

Quinn JV, Stiell IG, McDermott DA, Sellers KL, Kohn MA, Wells GA. Derivation of the San Francisco Syncope Rule to predict patients with short-term serious outcomes. Ann Emerg Med. 2004 Feb;43(2):224-32. doi: 10.1016/s0196-0644(03)00823-0.

Quinn J, McDermott D, Stiell I, Kohn M, Wells G. Prospective validation of the San Francisco Syncope Rule to predict patients with serious outcomes. Ann Emerg Med. 2006 May;47(5):448-54. doi: 10.1016/j.annemergmed.2005.11.019. Epub 2006 Jan 18.

Costantino G, Perego F, Dipaola F, Borella M, Galli A, Cantoni G, Dell'Orto S, Dassi S, Filardo N, Duca PG, Montano N, Furlan R; STePS Investigators. Short- and long-term prognosis of syncope, risk factors, and role of hospital admission: results from the STePS (Short-Term Prognosis of Syncope) study. J Am Coll Cardiol. 2008 Jan 22;51(3):276-83. doi: 10.1016/j.jacc.2007.08.059.

Del Rosso A, Ungar A, Maggi R, Giada F, Petix NR, De Santo T, Menozzi C, Brignole M. Clinical predictors of cardiac syncope at initial evaluation in patients referred urgently to a general hospital: the EGSYS score. Heart. 2008 Dec;94(12):1620-6. doi: 10.1136/hrt.2008.143123. Epub 2008 Jun 2.

Cheung CC, Kerr CR, Krahn AD. Comparing 14-day adhesive patch with 24-h Holter monitoring. Future Cardiol. 2014 May;10(3):319-22. doi: 10.2217/fca.14.24.

Bass EB, Curtiss EI, Arena VC, Hanusa BH, Cecchetti A, Karpf M, Kapoor WN. The duration of Holter monitoring in patients with syncope. Is 24 hours enough? Arch Intern Med. 1990 May;150(5):1073-8.

Tattersall LC, Reed MJ. The inpatient management of syncope. Emerg Med J. 2010 Nov;27(11):870-2. doi: 10.1136/emj.2010.092924. Epub 2010 Aug 3.

Task Force for the Diagnosis and Management of Syncope; European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA); Heart Failure Association (HFA); Heart Rhythm Society (HRS); Moya A, Sutton R, Ammirati F, Blanc JJ, Brignole M, Dahm JB, Deharo JC, Gajek J, Gjesdal K, Krahn A, Massin M, Pepi M, Pezawas T, Ruiz Granell R, Sarasin F, Ungar A, van Dijk JG, Walma EP, Wieling W. Guidelines for the diagnosis and management of syncope (version 2009). Eur Heart J. 2009 Nov;30(21):2631-71. doi: 10.1093/eurheartj/ehp298. Epub 2009 Aug 27. No abstract available.

Rosenberg MA, Samuel M, Thosani A, Zimetbaum PJ. Use of a noninvasive continuous monitoring device in the management of atrial fibrillation: a pilot study. Pacing Clin Electrophysiol. 2013 Mar;36(3):328-33. doi: 10.1111/pace.12053. Epub 2012 Dec 13.

Tung CE, Su D, Turakhia MP, Lansberg MG. Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA. Front Neurol. 2015 Jan 12;5:266. doi: 10.3389/fneur.2014.00266. eCollection 2014.

Barrett PM, Komatireddy R, Haaser S, Topol S, Sheard J, Encinas J, Fought AJ, Topol EJ. Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am J Med. 2014 Jan;127(1):95.e11-7. doi: 10.1016/j.amjmed.2013.10.003. Epub 2013 Oct 15.

Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014 Mar;15(2):194-8. doi: 10.5811/westjem.2013.11.18973.

Turakhia MP, Hoang DD, Zimetbaum P, Miller JD, Froelicher VF, Kumar UN, Xu X, Yang F, Heidenreich PA. Diagnostic utility of a novel leadless arrhythmia monitoring device. Am J Cardiol. 2013 Aug 15;112(4):520-4. doi: 10.1016/j.amjcard.2013.04.017. Epub 2013 May 11.

Camm CF, Tichnell C, James CA, Murray B, Porterfield F, Te Riele AS, Tandri H, Calkins H. Premature ventricular contraction variability in arrhythmogenic right ventricular dysplasia/cardiomyopathy. J Cardiovasc Electrophysiol. 2015 Jan;26(1):53-7. doi: 10.1111/jce.12544. Epub 2014 Oct 27.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Reed MJ, Grubb NR, Lang CC, Gray AJ, Simpson K, MacRaild A, Weir CJ. Diagnostic yield of an ambulatory patch monitor in patients with unexplained syncope after initial evaluation in the emergency department: the PATCH-ED study. Emerg Med J. 2018 Aug;35(8):477-485. doi: 10.1136/emermed-2018-207570. Epub 2018 Jun 19.

• Responsible Party: NHS Lothian
• ClinicalTrials.gov Identifier: NCT02683174
• Other Study ID Numbers: 2015/0225; 179127 ( Other Grant/Funding Number: IRAS project ID ); 19511 ( Other Identifier: UKCRN portfolio ID )
• First Submitted: February 5, 2016
• First Posted: February 17, 2016
• Results First Submitted: September 16, 2019
• Results First Posted: December 3, 2019
• Last Update Posted: December 3, 2019