ASPIRED Study

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

 

Aspired Logo

Chief Investigator: Dr Matt Reed

Number and location of participating sites (by region/ country): 25 UK sites

EudraCT number: n/a

ISRCTN number: ID number 52042     https://hub.crncc.nihr.ac.uk/

 

Funder: British Heart Foundation

Start and End date

Of grant award: 01 Aug 2022 – 31 Jul 2025

Of recruitment: 30 March 2022 – 30 August 2023

Current Status: In set up

Trial Website: https://www.emergeresearch.org/trial/aspired/

 

 

Study Protocol:

ASPIRED Protocol V6.0 (1.01 MB / 0_01)

 

Patient Information Sheets:

ASPIRED PISCF V7.0 (338.36 KB / 0)

 

SAP, HEAP and DSP:

ASPIRED SAP v1.0 signed (1.06 MB / 0_-_SIGNED)
ASPIRED Heap signed (1.27 MB / PDF)
ASPIRED Data Sharing Plan v1.0 (174.19 KB / 0_09_01_2023)

 

Please follow this link to view the ASPIRED Preventice Participant Video:

https://vimeo.com/736584068/d52656afb6

 

Health Economics: School of Health and Related Research, University of Sheffield

Regent Court,  30 Regent Street, Sheffield

Email: ASPIRED.Study@ed.ac.uk

 

UK GDPR Privacy Statement: As part of the PIS (currently pending approval)

Participant area: 

Sponsor: Accord, https://www.accord.scot/

 

Chief Investigator:

Dr Matt Reed, Consultant and Honorary Senior Lecturer in Emergency Medicine, Emergency Dept., Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA.

matthew.reed@nhslothian.scot.nhs.uk

Trial Manager:

Lynn Dinsmore,  Edinburgh Clinical Trials Unit,  Usher Institute, University of Edinburgh, Edinburgh BioQuarter, 5-7 Little France Road, Edinburgh EH16 4UX Lynn.Dinsmore@ed.ac.uk

 

ECTU involvement: Trial Management, Statistics, Database and randomisation service

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