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

NCT02683174 | Completed Results

• 3 other identifiers: 2015/022517912719511
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Syncope

Keywords

syncope

Outcome Measures

Primary Outcomes (1)

• Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia

  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.

  90 days

Secondary Outcomes (6)

• Median Time to Detection of Significant Symptomatic Arrhythmia

  90 days

• 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 Significant Arrhythmia Requiring Referral.

  90 days

Study Arms (1)

Single study arm

EXPERIMENTAL

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

Device: Novel ambulatory patch (ZIO® XT Patch); Biological: BNP and hs-troponin I at 0 and 3 hours post ED attendance

Interventions

Novel ambulatory patch (ZIO® XT Patch) DEVICE

All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch)

Single study arm

BNP and hs-troponin I at 0 and 3 hours post ED attendance BIOLOGICAL

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.

Single study arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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),

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

Related Publications (21)

• 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.

  PMID: 20170806 BACKGROUND

• 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.

  PMID: 21288597 BACKGROUND

• 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.

  PMID: 9095005 BACKGROUND

• 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.

  PMID: 10030311 BACKGROUND

• 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.

  PMID: 12727148 BACKGROUND

• 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.

  PMID: 14644781 BACKGROUND

• 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.

  PMID: 14747812 BACKGROUND

• 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.

  PMID: 16631985 BACKGROUND

• 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.

  PMID: 18206736 BACKGROUND

• 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.

  PMID: 18519550 BACKGROUND

• 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.

  PMID: 24976467 BACKGROUND

• 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.

  PMID: 2331188 BACKGROUND

• 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.

  PMID: 20682959 BACKGROUND

• 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.

  PMID: 19713422 BACKGROUND

• 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.

  PMID: 23240827 BACKGROUND

• 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.

  PMID: 25628595 BACKGROUND

• 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.

  PMID: 24384108 BACKGROUND

• 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.

  PMID: 24672611 BACKGROUND

• 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.

  PMID: 23672988 BACKGROUND

• 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.

  PMID: 25215858 BACKGROUND

• 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.

  PMID: 29921622 DERIVED

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Matt Reed
• Organization: NHS Lothian

Matthew.Reed@nhslothian.scot.nhs.uk

+44 131 242 1448

Study Officials

• Matthew J Reed, MA FCEM MD

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 17, 2016
• Study Start: November 1, 2015
• Primary Completion: June 13, 2017
• Study Completion: September 13, 2017
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available from 6 months after final publication with no end date.
• Access Criteria: Please contact CI

Locations

GB (1)