Ambulatory ECG monitor versus standard care in acute unexplained syncope (sudden loss of consciousness also known as blackout or fainting)
| ISRCTN | ISRCTN10278811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10278811 |
| IRAS number | 304917 |
| Secondary identifying numbers | CPMS 52042, Protocol Number AC21115, IRAS 304917 |
- Submission date
- 25/03/2022
- Registration date
- 19/04/2022
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
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.
Who can participate?
Adults aged 16 years or older who attend hospital following a blackout, and after initial assessment it is still unclear what caused the blackout.
What does the study involve?
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.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
University of Edinburgh and NHS Lothian (UK)
When is the study starting and how long is it expected to run for?
August 2021 to June 2026
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
1. Dr Matthew Reed - Chief Investigator
mattreed@ed.ac.uk
2. Lynn Dinsmore - Trial Manager
Lynn.Dinsmore@ed.ac.uk
Contact information
Public
Edinburgh Clinical Trials Unit, Usher Institute
University of Edinburgh
Level 2, NINE Edinburgh BioQuarter
9 Little France Road
Edinburgh
EH16 4UX
United Kingdom
| ASPIRED.study@ed.ac.uk |
Principal Investigator
EMERGE, Acute Care Edinburgh
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
 ORCID ID |
0000-0003-1308-4824 |
|---|---|
| Phone | +44 (0)131 242 3863 |
| matthew.reed@nhslothian.scot.nhs.uk |
Scientific
Usher Institute
University of Edinburgh
Level 2, NINE Edinburgh BioQuarter
9 Little France Road
Edinburgh
EH16 4UX
United Kingdom
| lynn.dinsmore@ed.ac.uk |
Study information
| Study design | Multi-centre open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | https://www.ed.ac.uk/usher/edinburgh-clinical-trials/our-studies/all-current-studies/aspired-study |
| Scientific 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. |
| Study acronym | ASPIRED |
| Study hypothesis | To determine whether the immediate application of enhanced mobile heart monitoring will decrease the number of episodes of blackouts at 1 year compared to standard care monitoring in patients attending hospital with acute unexplained blackouts. |
| Ethics approval(s) | Approved 29/11/2021, South East Scotland Research Ethics Committee 01 (2nd Floor, Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 (0)131 536 9000; sandra.wyllie@nhslothian.scot.nhs.uk), ref: 21/SS/0073 |
| Condition | Early diagnosis of patients presenting to Emergency Departments with undiagnosed syncope (blackouts). |
| Intervention | 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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Boston Scientific Cardiac Diagnostics BodyGuardian Mini Ambulatory ECG Monitor |
| Primary outcome measure | Number 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. |
| Secondary outcome measures | 1. Within trial cost-effectiveness (cost per syncope avoided and cost per quality-adjusted life-year [QALY] gained), and lifetime cost per QALY at (a) 1 year and (b) 2 years measured by NHS resource utilisation data and EQ-5D-5L questionnaires. 2. Number of self-reported episodes of syncope at (a) 90 days and (b) 2 years, those identified in the medical records at (c) 90 days, (d) 1 year and (e) 2 years, and syncope recurrence rate at (f) 90 days, (g) 1 year and (h) 2 years measured from 4 weekly patient brief questionnaire and extraction of NHS resource utilisation data. 3. Index presentation hospital (a) admission rate and (b) duration of hospital stay measured using NHS resource utilisation data at 90 days 1 year and 2 years. 4. Patient satisfaction measured using a patient questionnaire at 1 year 5. Clinically significant cardiac dysrhythmia (serious and/or symptomatic cardiac dysrhythmia at (a) 90 days, (b) 1 year and (c) 2 years measured from NHS resource utilisation data. 6. (a) 30-day, (b) 1-year and (c) 2-year all-cause death as recorded from NHS resource utilisation data 7. Detection of diagnostic ECG/symptom correlation (symptomatic) at (a) 90 days, (b) 1 year and (c) 2 years measured from NHS resource utilisation data and participant self-reported 4 weekly brief questionnaires. 8. Time to detect clinically significant cardiac dysrhythmia (i.e. time to clinician being aware) measured from NHS resource utilisation data at 90 days, 1 year and 2 years. For the intervention group data from the ambulatory ECG monitoring report which will be provided at the end of the 14-day monitoring period. 9. In the intervention group, the duration of enhanced ambulatory ECG monitoring required to detect clinically significant cardiac dysrhythmia measured using data from the ambulatory ECG monitoring report at 90 days 10. Number and type of diagnostic tests and therapeutic interventions at (a) 1 year and (b) 2 years measured from the NHS resource utilisation extraction data |
| Overall study start date | 01/08/2021 |
| Overall study end date | 24/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 2,234 |
| Total final enrolment | 2234 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 15/07/2022 |
| Recruitment end date | 24/06/2024 |
Locations
Countries of recruitment
- England
- Jersey
- Scotland
- United Kingdom
- Wales
Study participating centres
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Taunton
TA1 5DA
United Kingdom
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom
London
E1 1FR
United Kingdom
London
SW17 0QT
United Kingdom
Southampton
SO16 6YD
United Kingdom
Glasgow
G51 4TF
United Kingdom
Livingston
EH54 6PP
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Derriford
Plymouth
PL6 8DH
United Kingdom
C Floor, Huntsmnan Building
Herries Road
Sheffield
S5 7AU
United Kingdom
Derby
DE22 3NE
United Kingdom
St Hellier
JE1 3QS
Jersey
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
London
SE1 7EH
United Kingdom
Edinburgh
Lothian
EH4 2XU
United Kingdom
Stockton -on- Tees
TS19 8PE
United Kingdom
Larbert
FK5 4WR
United Kingdom
Walsgrave
Coventry
CV2 2DX
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Kettering
NN16 8UZ
United Kingdom
Warwick
CV34 5BW
United Kingdom
Ayr
KA6 6DX
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Cramlington
NE23 6NZ
United Kingdom
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Leeds
LS1 3EX
United Kingdom
London
SW10 9NH
United Kingdom
Paisley
PA2 9PN
United Kingdom
Hull
HU3 2JZ
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Willesborough
Ashford
TN24 0LZ
United Kingdom
Lincoln
LN2 5QY
United Kingdom
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
Wrexham Technology Park
Wrexham
LL13 7TD
United Kingdom
Glen Road
London
E13 8SL
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Burton-on-trent
DE13 0RB
United Kingdom
De Crespigny Park
Denmark Hill
London
SE5 8AB
United Kingdom
London
NW1 2PG
United Kingdom
Sponsor information
University/education
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 3330 |
|---|---|
| enquiries@accord.scot | |
| Website | http://accord.scot/ |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Anonymised study Individual participant data (IPD) and metadata generated and/or analysed during the current study will be available on request. In the first instance, email requests should be made via email to ECTUdatashare@ed.ac.uk. Study data and metadata will be available for as long as it has been retained. Once the completed application form has been received, a review panel will review the application form. The review panel will consider the following: Permissions listed in ASPIRED Ethics/Patient Information Sheet Consent Form (PISCF); Risk of identification; Risk of affecting ASPIRED study outcomes/data access embargo date; Stage of study; Requester evaluation (e.g. relationship to Chief Investigator, Edinburgh Clinical Trials Unit etc); Scientific merit of proposed data use; Overlap with other study projects; and Permissions (i.e. ethical, information governance) in place for proposed data use. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 23/02/2023 | 24/02/2023 | Yes | No | |
| Other publications | Results from an embedded qualitative study focused on patient and healthcare professional usability and acceptability | 08/04/2025 | 23/04/2025 | Yes | No |
Editorial Notes
23/04/2025: Publication reference added.
17/07/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/07/2024 to 24/06/2024.
2. The overall end date was changed from 31/07/2026 to 24/06/2026.
3. The intention to publish date was changed from 31/07/2026 to 31/12/2026.
4. Total final enrolment added.
5. The study participating centres were updated to remove University Hospital of Wales, Glasgow Royal Infirmary and Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus and add Warwick Hospital, University Hospital Ayr, North West Anglia NHS Foundation Trust, Milton Keynes Hospital, Northumbria Specialist Emergency Care Hospital, Epsom & St Helier University Hospitals NHS Trust, Leeds General Infirmary, Chelsea & Westminster Hospital, Royal Alexandra Hospital, Hull Royal Infirmary, Salisbury District Hospital, William Harvey Hospital, Lincoln County Hospital, Imperial College Healthcare Trust, Wrexham Maelor Hospital, Newham University Hospital, Gloucester Royal Hospital, Salford Royal Hospital, Queens Hospital Burton, Kings College Hospital and University College London Hospital.
11/01/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 14/01/2024 to 31/07/2024.
2. The overall end date was changed from 31/07/2025 to 31/07/2026.
3. The plain English summary was updated to reflect these changes.
10/10/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 14/01/2024.
2. The device name was added.
24/02/2023: Publication reference added.
06/02/2023: University Hospital Coventry & Warwickshire, Chesterfield Royal Hospital NHS Foundation Trust and Kettering General Hospital were added as trial participating centres.
02/02/2023: The participant level data sharing statement was added.
26/07/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/07/2022 to 15/07/2022.
2. The recruitment end date was changed from 30/11/2023 to 31/12/2023.
3. Contact details updated.
16/06/2022: The recruitment start date has been changed from 01/06/2022 to 01/07/2022.
10/05/2022: The recruitment start date was changed from 01/05/2022 to 01/06/2022.
25/03/2022: Trial's existence confirmed by the South East Scotland Research Ethics Committee 01.
