ASPIRED Ambulatory ECG monitor v Standard in acute unexplained syncope

• Research type

  Research Study

• Full title

  Multi-centre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: The ASPIRED study.

• IRAS ID

  304917

• Contact name

  Matthew Reed

• Contact email

  matthew.reed@nhslothian.scot.nhs.uk

• Sponsor organisation

  University of Edinburgh

• ISRCTN Number

  ISRCTN10278811

• Clinicaltrials.gov Identifier

  n/a, n/a

• Duration of Study in the UK

  3 years, 9 months, 31 days

• Research summary

  Syncope (sudden loss of consciousness also known as blackout or fainting) causes over 600,000 people to visit emergency departments every year in the UK. Often, by the time the patient is seen by the medical team they have fully recovered making it hard to diagnose the underlying problem.
  A mobile heart ECG monitoring device has recently been developed (BodyGuardian Mini; Preventice Solutions). This device can record the patients heartbeat and heart electrical rhythm tracing for up to 14 days. By applying the mobile heart monitor after attendance at the emergency department we hope to have a better chance of diagnosing the underlying problem that caused the syncope.
  2234 adults 16 years or older presenting with syncope remaining unexplained after initial assessment will be recruited from ~26 NHS hospitals. Participants will be randomised between two study arms to either receive the 14-day mobile heart monitoring device plus standard care, or standard care only.
  Potential participants will be identified from emergency departments or other acute settings whilst in hospital. Potential participants who are not approached in hospital will be identified using electronic medical records or referral from the clinical team then contacted by phone by the research team to invite them to take part in the study.
  The study will last for 4 years. Recruitment will take place over 18 months. All participants will be followed-up for 2 years. Once a month for 2 years participants will be contacted by text, email or phone call to complete a brief questionnaire of two questions; asking whether they have had any further episodes of sudden loss of consciousness, and the number of visits to their GP for any reason. All participants will also be asked to complete a short quality-of-life questionnaire at randomisation, one and two years. The questionnaire at one year will include a satisfaction survey

• REC name

  South East Scotland REC 01

• REC reference

  21/SS/0073

• Date of REC Opinion

  29 Nov 2021

• REC opinion

  Further Information Favourable Opinion