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

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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:
Information provided by (Responsible Party):
NHS Lothian

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.


Condition or disease Intervention/treatment Phase
Syncope Device: Novel ambulatory patch (ZIO® XT Patch) Biological: BNP and hs-troponin I at 0 and 3 hours post ED attendance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Yield of an Ambulatory Patch Monitor in Emergency Department Syncope Patients Unexplained After Emergency Department Evaluation: A Pilot Study (PATCH-ED)
Study Start Date : November 1, 2015
Actual Primary Completion Date : June 13, 2017
Actual Study Completion Date : September 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Experimental: 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
Device: Novel ambulatory patch (ZIO® XT Patch)
All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch)

Biological: 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.




Primary Outcome Measures :
  1. Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia [ Time Frame: 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.



Secondary Outcome Measures :
  1. Median Time to Detection of Significant Symptomatic Arrhythmia [ Time Frame: 90 days ]
    Median time to detection of significant symptomatic arrhythmia by ambulatory patch monitor

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

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

  4. Median Device Wear Time [ Time Frame: 14 days ]
    Patch compliance described by median device wear time

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

  6. Number of Participants With All Cause Serious Outcome [ Time Frame: 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



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683174


Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SA
Sponsors and Collaborators
NHS Lothian
Investigators
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Principal Investigator: Matthew J Reed, MA FCEM MD NHS Lothian
  Study Documents (Full-Text)

Documents provided by NHS Lothian:
Study Protocol  [PDF] April 2, 2015
No Statistical Analysis Plan (SAP) exists for this study.

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 Posted: February 17, 2016    Key Record Dates
Results First Posted: December 3, 2019
Last Update Posted: December 3, 2019
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available from 6 months after final publication
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available from 6 months after final publication with no end date.
Access Criteria: Please contact CI
Keywords provided by NHS Lothian:
syncope
Additional relevant MeSH terms:
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Syncope
Emergencies
Disease Attributes
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases