Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study
Introduction Diagnosing underlying arrhythmia in emergency department (ED) syncope patients is difficult. There is a evidence that diagnostic yield for detecting underlying arrhythmia is highest when cardiac monitoring devices are applied early, ideally at the index visit. This strategy has the pote...
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BMJ Publishing Group
2023-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/2/e069530.full |
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| author | Steve Goodacre Praveen Thokala Neil Grubb Chris Lang Rachel O’Brien Christopher J Weir Trudie Lobban Matthew J Reed Nicola Freeman Julia Boyd Lynn Dinsmore Caroline Blackstock Imad Adamestam Pam Macrae Robert Hannigan |
| author_facet | Steve Goodacre Praveen Thokala Neil Grubb Chris Lang Rachel O’Brien Christopher J Weir Trudie Lobban Matthew J Reed Nicola Freeman Julia Boyd Lynn Dinsmore Caroline Blackstock Imad Adamestam Pam Macrae Robert Hannigan |
| author_sort | Steve Goodacre |
| collection | DOAJ |
| description | Introduction Diagnosing underlying arrhythmia in emergency department (ED) syncope patients is difficult. There is a evidence that diagnostic yield for detecting underlying arrhythmia is highest when cardiac monitoring devices are applied early, ideally at the index visit. This strategy has the potential to change current syncope management from low diagnostic yield Holter to higher yield ambulatory monitoring, reduce episodes of syncope, reduce risk of recurrence and its potential serious consequences, reduce hospital admissions, reduce overall health costs and increase quality of life by allowing earlier diagnosis, treatment and exclusion of clinically important arrhythmias.Methods and analyses This is a UK open prospective parallel group multicentre randomised controlled trial of an immediate 14-day ambulatory patch heart monitor vs standard care in 2234 patients presenting acutely with unexplained syncope. Our patient focused primary endpoint will be number of episodes of syncope at 1 year. Health economic evaluation will estimate the incremental cost per syncope episode avoided and quality-adjusted life year gained.Ethics and dissemination Informed consent for participation will be sought. The ASPIRED trial received a favourable ethical opinion from South East Scotland Research Ethics Committee 01 (21/SS/0073). Results will be disseminated via scientific publication, lay summary and visual abstract.Trial registration number ISRCTN 10278811. |
| format | Article |
| id | doaj-art-1ba557d33bcd4cf0990d4d2bb470e668 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-02-01 |
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| spelling | doaj-art-1ba557d33bcd4cf0990d4d2bb470e6682025-08-20T03:15:24ZengBMJ Publishing GroupBMJ Open2044-60552023-02-0113210.1136/bmjopen-2022-069530Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED studySteve Goodacre0Praveen Thokala1Neil Grubb2Chris Lang3Rachel O’Brien4Christopher J Weir5Trudie Lobban6Matthew J Reed7Nicola Freeman8Julia Boyd9Lynn Dinsmore10Caroline Blackstock11Imad Adamestam12Pam Macrae13Robert Hannigan14School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UKSchool of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UKDepartment of Cardiology, Royal Infirmary Edinburgh, Edinburgh, UKDepartment of Cardiology, Royal Infirmary Edinburgh, Edinburgh, UKEmergency Medicine Research Group Edinburgh (EMERGE), Royal Infirmary of Edinburgh, Edinburgh, UK4 Edinburgh Clinical Trials Unit, The University of Edinburgh, Usher Institute of Population Health Sciences and Informatics, Edinburgh, UKArrythmia Alliance, Swansea, UKRoyal Infirmary of Edinburgh, Edinburgh, UK1 Emergency Medicine Research Group Edinburgh (EMERGE), Royal Infirmary of Edinburgh, Edinburgh, UK5 Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, 3 Little France Road, Edinburgh, UKEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UKEmergency Medicine Research Group Edinburgh (EMERGE), Royal Infirmary of Edinburgh, Edinburgh, UKEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UKASPIRED study Patient Advisory Group, Edinburgh, UKASPIRED study Patient Advisory Group, Edinburgh, UKIntroduction Diagnosing underlying arrhythmia in emergency department (ED) syncope patients is difficult. There is a evidence that diagnostic yield for detecting underlying arrhythmia is highest when cardiac monitoring devices are applied early, ideally at the index visit. This strategy has the potential to change current syncope management from low diagnostic yield Holter to higher yield ambulatory monitoring, reduce episodes of syncope, reduce risk of recurrence and its potential serious consequences, reduce hospital admissions, reduce overall health costs and increase quality of life by allowing earlier diagnosis, treatment and exclusion of clinically important arrhythmias.Methods and analyses This is a UK open prospective parallel group multicentre randomised controlled trial of an immediate 14-day ambulatory patch heart monitor vs standard care in 2234 patients presenting acutely with unexplained syncope. Our patient focused primary endpoint will be number of episodes of syncope at 1 year. Health economic evaluation will estimate the incremental cost per syncope episode avoided and quality-adjusted life year gained.Ethics and dissemination Informed consent for participation will be sought. The ASPIRED trial received a favourable ethical opinion from South East Scotland Research Ethics Committee 01 (21/SS/0073). Results will be disseminated via scientific publication, lay summary and visual abstract.Trial registration number ISRCTN 10278811.https://bmjopen.bmj.com/content/13/2/e069530.full |
| spellingShingle | Steve Goodacre Praveen Thokala Neil Grubb Chris Lang Rachel O’Brien Christopher J Weir Trudie Lobban Matthew J Reed Nicola Freeman Julia Boyd Lynn Dinsmore Caroline Blackstock Imad Adamestam Pam Macrae Robert Hannigan Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study BMJ Open |
| title | Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study |
| title_full | Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study |
| title_fullStr | Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study |
| title_full_unstemmed | Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study |
| title_short | Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study |
| title_sort | multicentre open label randomised controlled trial of immediate enhanced ambulatory ecg monitoring versus standard monitoring in acute unexplained syncope patients the aspired study |
| url | https://bmjopen.bmj.com/content/13/2/e069530.full |
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