Multi-centre open-label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study.
Early diagnosis of patients presenting to Emergency Departments with undiagnosed syncope (blackouts).
Participants will be randomised, 1:1, between the two study arms. Randomisation will be performed using a web-based randomisation service to ensure allocation concealment. The allocation sequence will be created by a database programmer using computer-generated pseudo-random numbers. Stratification by site will be used to ensure balanced randomisation. Participants randomised to the intervention arm will be fitted with a 14-day ambulatory heart monitor (Preventice BodyGuardian Mini) applied by the study team as soon after ED attendance and randomisation as possible. The participant will wear the ambulatory ECG monitor for a maximum of 14 days after which they will remove the monitor and return it to Preventice UK for reporting by an ECG technician. The ECG report will be shared with the local study team. Participants in both control and intervention arms will receive standard care which will include all care usually given to unexplained syncope patients at each participating site along with some form of standard care monitoring such as but not limited to wired inpatient telemetry, Holter style monitoring or implantable loop recorder. All participants will be followed up for 2 years from randomisation through hospital records, questionnaires and participant-reported events. Participants will be contacted at monthly intervals throughout the study follow-up by automated text or email (participant preference) with a link to a brief web-based questionnaire. Those who are unable to access digital forms of communication will receive phone calls. Participants will also be contacted at 1 and 2 years to complete a quality-of-life questionnaire. The participants’ involvement in the study will cease at 2 years.
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
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