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

BHF (CS/F/20/190016); £1,303,649 over 4 years

Lay summary:

Diagnosing underlying dysrhythmia in people presenting to the emergency department is difficult. There is evidence that the diagnostic yield for detecting underlying dysrhythmia is highest when cardiac monitoring devices are applied early in patients with acute unexplained syncope, ideally at the index visit.

The ASPIRED study is a UK open label, prospective parallel group multicentre randomised controlled trial of an immediate 14-day ambulatory patch heart monitor versus standard care (Holter/extended ambulatory monitor as per NICE guidance) in over 2,000 people presenting acutely with unexplained syncope to over 30 UK hospitals.

The primary endpoint will be the number of episodes of syncope at one year. Secondary end points include cost effectiveness, the number of episodes of syncope at 90 days and 2 years, clinically significant cardiac dysrhythmia, all cause death and quality of life.

Recruitment commenced July 2022 and will take place over 18 months. We are no longer looking for new sites.

ASPIRED protocol

ASPIRED PIS/Consent

SAP, HEAP and DSP

ASPIRED Preventice Participant Video

Site recruitment video – all you need to know

More detailed slideset about study

ECTU website

Chief Investigator:

Professor Matt Reed, Consultant and Honorary Senior Lecturer in Emergency Medicine, Emergency Dept., Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA mattreed@ed.ac.uk

Trial Manager:

Lynn Dinsmore,  ECTU, University of Edinburgh, Level 2, NINE Edinburgh BioQuarter, 9 Little France Road, Edinburgh EH16 4UX Lynn.Dinsmore@ed.ac.uk

Investigator’s meeting:

ASPIRED Investigators’ meeting programme

ASPIRED Investigators’ meeting expenses claim form (word doc)

ASPIRED Investigators’ meeting expenses claim form (pdf)