PATCH-ED

Start date:
November 2015

End date:
February 2015

Co-ordinated by:
NHS Lothian

Main trial site:
RIE

Diagnostic yield of an ambulatory patch monitor in Emergency Department syncope patients unexplained after Emergency Department evaluation – a pilot study (PATCH-ED)

EMERGE are excited to announce the PATCH-ED study – aiming to recruit 100 patients, PATCH-ED will involve an ambulatory patch monitor being applied to monitor heart beats for 14 days in eligible patients who present with an episode of syncope that remains unexplained after full ED assessment. A patch report will be provided by iRhythm Technologies, Inc. San Francisco, CA enabling any arrhythmias to be identified and informing appropriate follow-up.

Study Aims: PATCH-ED aims to investigate the diagnostic yield, prevalence of events captured on patch monitor, patient satisfaction of patch monitor, patch compliance and influence on subsequent treatment in ED syncope patients.

Study endpoints

Primary: Diagnostic yield of the ambulatory patch monitor for significant symptomatic arrhythmia at 90-day follow-up versus standard care strategies.

Sponsor: This study is sponsored by NHS Lothian.

Funding: Chest, Heart and Stroke Scotland

Setting: This is a single centre study being carried out in a teaching hospital ED, RIE.

Study Population: Patients presenting with an episode of syncope who after full ED assessment have no cause of syncope identified.

Eligibility Criteria

Inclusion criteria:

• Patient presents within 6 hours of episode of syncope
• Patient >16 years old
• Syncope episode remains unexplained after ED assessment
• Able to provide written informed consent

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
• Epileptic seizure (seizure activity with a >15 min witness reported post-ictal phase)
• Stroke ⁄ transient ischemic attack
• Head trauma
• Hypoglycemia
• 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
• Arrhythmia on ED ECG thought to have caused syncope
• Arrhythmia on pre-hospital ECG causing syncope
• Pulmonary embolism diagnosed on CTPA (or equivalent e.g. symptoms of PE plus positive leg USS/VQ/echo)
• Postural hypotension (postural drop >20 mmHg in ED with symptoms during test and suggestive history)
• Myocardial Infarction

Chief Investigator:

Dr Matthew Reed

Research Team:

Kirsty Simpson, Research Nurse

Publications:

1. Reed MJ,BrutinH, Grubb NJ, Lang CC, GrayAJ, SimpsonK, MaCraild AJ, WeirCJ.P420 Brain Natriuretic Peptide (BNP) and high-sensitivity troponin I at 3 hours post Emergency Department (ED) attendance predicts all significant arrhythmias at 3 months in unexplained ED syncope patients. EP Europace 2018;20 (suppl 1): i78–i79; https://doi.org/10.1093/europace/euy015.231
2. Reed MJ,Grubb NJ, Lang CC, GrayAJ, SimpsonK, MaCraild AJ, WeirCJ.Diagnostic yield of an ambulatory patch monitor in patients with unexplained syncope after initial evaluation in the Emergency Department: The PATCH-ED study. EP Europace2018; 20 (suppl 1): i79; https://doi.org/10.1093/europace/euy015.233