Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Matt Reed
+44 (0)131 242 3863
matthew.reed@nhslothian.scot.nhs.uk


Mrs Lynn Dinsmore
-
lynn.dinsmore@ed.ac.uk


Mrs Lynn Dinsmore
-
ASPIRED.study@ed.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Ambulatory ECG monitor versus standard care in acute unexplained syncope (sudden loss of consciousness also known as blackout or fainting)

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

Medical Conditions

Early diagnosis of patients presenting to Emergency Departments with undiagnosed syncope (blackouts).


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 patient’s heartbeat and heart electrical rhythm tracing for up to 14 days. By wearing the mobile heart monitor after attendance at the Emergency Department there may be a better chance of finding an underlying problem that caused the blackout. This study aims to recruit people who, after investigation at the Emergency Department a cause hasn’t been found for their episode of blackout. The goal is to discover if by providing patients with a 14-day mobile heart ECG monitor, doctors can better diagnose and treat the cause of a sudden loss of consciousness and reduce the number of further episodes and their potential serious consequences (i.e. injury, anxiety, poor quality of life and on rare occasions, death), reduce hospital admissions, reduce overall health costs and increase quality of life. At the moment it is not known how long patients who have this type of monitor should be monitored for, so this study will also answer this question.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Jul 2022 24 Jun 2024

Publications

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

Participants are allocated to one of two groups. One group will be fitted with the mobile heart monitor to wear for 14 days and will also receive standard care which may mean being referred to a specialist clinic in the hospital. The other group will not be given the heart monitor but will receive standard care which may include the use of a standard heart monitor and being referred to a specialist clinic in the hospital. Everyone who takes part in the study will be contacted once a month for 2 years either by text, email or phone call to complete a very brief questionnaire comprising of two questions. Participants will also be asked to complete a quality-of-life questionnaire when they start the study and in 1 and 2 years' time asking how they are feeling and about day-to-day activities. Finally in 1 years’ time participants will be asked to complete a satisfaction questionnaire.


Adults aged 16 years or older who attend hospital following a blackout, and after initial assessment it is still unclear what caused the blackout.

You can take part if:



You may not be able to take part if:


1. Obvious underlying cause after assessment:1.1. Features of vasovagal syncope AND absence of structural heart disease AND normal physical examination AND normal ECG1.2. 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 Infarction1.5. Radiological diagnosis or clinical signs/symptoms of cerebrovascular accident/transient ischemic attack or subarachnoid haemorrhage1.6. Evidence of: 1.6.1. Haemorrhage1.6.2. Alcohol or illicit drugs1.6.3. Epileptic seizure1.6.4. Hypoglycemia1.6.5. Head trauma1.6.6. Other obvious cause of syncope as presumptive cause of TLoC2. Inability to consent3. Previous recruitment into the study4. Patient in custody or prison5. Aged <16 years6. 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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • North West Anglia NHS Foundation Trust
    Peterborough City Hospital Bretton Gate Bretton
    Peterborough
    PE3 9GZ
  • Salisbury District Hospital
    Salisbury District Hospital Odstock Road
    Salisbury
    SP2 8BJ
  • Southmead Hospital
    Southmead Road Westbury-on-trym
    Bristol
    BS10 5NB
  • University College London Hospitals NHS Foundation Trust
    250 Euston Road
    London
    NW1 2PG
  • Aberdeen Royal Infirmary
    Foresterhill Road
    Aberdeen
    AB25 2ZN
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • Southampton General Hospital
    Tremona Road
    Southampton
    SO16 6YD
  • Hull Royal Infirmary
    Anlaby Road
    Hull
    HU3 2JZ
  • Royal Infirmary of Edinburgh
    NHS Lothian 51 Little France Crescent
    Edinburgh
    EH16 4SA
  • Taunton Hospital
    Musgrove Park Hospital
    Taunton
    TA1 5DA
  • NHS Fife
    Hayfield House Hayfield Road
    Kirkcaldy
    KY2 5AH
  • Royal London Hospital
    Whitechapel
    London
    E1 1FR
  • St George's Hospital
    Blackshaw Road
    London
    SW17 0QT
  • Queen Elizabeth University Hospital
    1345 Govan Road
    Glasgow
    G51 4TF
  • St Johns Hospital
    Howden West Road
    Livingston
    EH54 6PP
  • Addenbrookes
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ
  • Royal Berkshire Hospital
    Royal Berkshire Hospital London Road
    Reading
    RG1 5AN
  • Derriford Hospital
    Derriford Road Derriford
    Plymouth
    PL6 8DH
  • Northern General Hospital
    Northern General Hospital NHS Trust C Floor, Huntsmnan Building Herries Road
    Sheffield
    S5 7AU
  • Royal Derby Hospital
    Uttoxeter Road
    Derby
    DE22 3NE
  • Jersey General hospital
    Gloucester Street
    St Hellier
    JE1 3QS
  • Glan Clwd Hospital
    Ysbyty Glan Clwydd Bodelwyddan
    Rhyl
    LL18 5UJ
  • St. Thomas's Hospital
    Westminster Bridge Road
    London
    SE1 7EH
  • Western General Hospital
    Crewe Road South Edinburgh
    Lothian
    EH4 2XU
  • University Hospital of North Tees
    Hardwick road
    Stockton -on- Tees
    TS19 8PE
  • Forth Valley Royal Hospital
    Stirling Road
    Larbert
    FK5 4WR
  • University Hospital Coventry & Warwickshire
    Clifford Bridge Road Walsgrave
    Coventry
    CV2 2DX
  • Chesterfield Royal Hospital NHS Foundation Trust
    Chesterfield Road Calow
    Chesterfield
    S44 5BL
  • Kettering General Hospital
    Rothwell Road
    Kettering
    NN16 8UZ
  • Leeds General Infirmary
    Great George Street
    Leeds
    LS1 3EX
  • Imperial College Healthcare NHS Trust
    The Bays St Marys Hospital South Wharf Road
    London
    W2 1BL
  • Queens Hospital
    Belvedere Road
    Burton-on-trent
    DE13 0RB
  • William Harvey Hospital
    Kennington Road Willesborough
    Ashford
    TN24 0LZ
  • Kings College Hospital
    Mapother House De Crespigny Park Denmark Hill
    London
    SE5 8AB
  • Salford Royal Hospital
    Stott Lane Eccles
    Salford
    M6 8HD
  • Gloucester Royal Hospital
    Great Western Road
    Gloucester
    GL1 3NN
  • Warwick Hospital
    Lakin Road
    Warwick
    CV34 5BW
  • Chelsea & Westminster Hospital
    369 Fulham Road
    London
    SW10 9NH
  • Northumbria Specialist Emergency Care Hospital
    Northumbria Way
    Cramlington
    NE23 6NZ
  • Lincoln County Hospital
    Greetwell Road
    Lincoln
    LN2 5QY
  • Epsom and St Helier University Hospitals NHS Trust
    St Helier Hospital Wrythe Lane
    Carshalton
    SM5 1AA
  • University Hospital Ayr
    Dalmellington Road
    Ayr
    KA6 6DX
  • Wrexham Maelor Hospital
    Croesnewydd Road Wrexham Technology Park
    Wrexham
    LL13 7TD
  • Milton Keynes General Hospital
    Milton Keynes Hospital Standing Way Eaglestone
    Milton Keynes
    MK6 5LD
  • Newham University Hospital NHS Trust
    Newham General Hospital Glen Road
    London
    E13 8SL
  • Royal Alexandra Hospital
    Corsebar Road
    Paisley
    PA2 9PN

For the group allocated to wear the 14-day mobile heart ECG monitor, there is the possibility that the researchers may find a heart-related problem that may not have been detected otherwise. This information would be shared with the Specialist team at the hospital to arrange appropriate further tests and treatments as necessary. Otherwise, there are no direct benefits to taking part in this study, but the results from this study might help to improve the healthcare of patients in the future.

Mrs Lynn Dinsmore
-
lynn.dinsmore@ed.ac.uk


Dr Matt Reed
+44 (0)131 242 3863
matthew.reed@nhslothian.scot.nhs.uk


Mrs Lynn Dinsmore
-
ASPIRED.study@ed.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by The University of Edinburgh and Lothian Health Board ACCORD and funded by British Heart Foundation.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: ISRCTN10278811

Or CPMS 52042

Last updated 17 July 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.