Clinical Trial Details
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NCT02683174 : Diagnostic Yield of an Ambulatory Patch Monitor in Unexplained Emergency Department Syncope: A Pilot Study (PATCH-ED)
AgesMin: 16 Years Max: N/A
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.
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