Ambulatory ECG monitor versus standard care in acute unexplained syncope (sudden loss of consciousness also known as blackout or fainting)

Not Applicable

• Conditions: Early diagnosis of patients presenting to Emergency Departments with undiagnosed syncope (blackouts).; Signs and Symptoms; Syncope and collapse

• Registration Number: ISRCTN10278811
• Lead Sponsor: The University of Edinburgh and Lothian Health Board ACCORD

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36822806/ (added 24/02/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-19
• Last Update Posted: 29 July 2024
• Study Completion: 2026-06-24

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2234

Inclusion Criteria

1. Syncope remains unexplained after initial ED/AMU assessment.
2. Aged =16 years
3. Patient has capacity
4. Local resident (i.e. resident within local health board so will not be lost to medical record follow up)
5. Less than five self-reported episodes of syncope in the previous month

Exclusion Criteria

1. Obvious underlying cause after assessment:
1.1. Features of vasovagal syncope AND absence of structural heart disease AND normal physical examination AND normal ECG
1.2. Dysrhythmia on pre-hospital or hospital ECG as likely cause of syncope
1.3. Postural hypotension (symptomatic postural drop >20 mmHg AND suggestive history)
1.4. Confirmed diagnosis of Pulmonary Embolus or Acute Myocardial Infarction
1.5. Radiological diagnosis or clinical signs/symptoms of cerebrovascular accident/transient ischemic attack or subarachnoid haemorrhage
1.6. Evidence of:
1.6.1. Haemorrhage
1.6.2. Alcohol or illicit drugs
1.6.3. Epileptic seizure
1.6.4. Hypoglycemia
1.6.5. Head trauma
1.6.6. Other obvious cause of syncope as presumptive cause of TLoC
2. Inability to consent
3. Previous recruitment into the study
4. Patient in custody or prison
5. Aged <16 years
6. Patient does not reside within local health board and will therefore be lost to medical record follow up
7. Five or more self-reported episodes of syncope in the previous 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of self-reported episodes of syncope at 1 year. Participants will be contacted at monthly intervals throughout the study follow-up which will last for 2 years, by automated text or email (participant preference) with a link to a brief web-based questionnaire asking for the number of syncope events experienced since their last response and how many of these they attended hospital for. Those who are unable to access digital forms of communication will receive phone calls.