Abstract
Background
The majority of patients with suspected acute coronary syndrome presenting to the emergency department will be discharged once myocardial infarction has been ruled out, although a proportion will have unrecognised coronary artery disease. In this setting, high-sensitivity cardiac troponin identifies those at increased risk of future cardiac events. In patients with intermediate cardiac troponin concentrations in whom myocardial infarction has been ruled out, this trial aims to investigate whether outpatient computed tomography coronary angiography (CTCA) reduces subsequent myocardial infarction or cardiac death.
Methods
TARGET-CTCA is a multicentre prospective randomised open label with blinded endpoint parallel group event driven trial. After myocardial infarction and clear alternative diagnoses have been ruled out, participants with intermediate cardiac troponin concentrations (5 ng/L to 99th centile upper reference limit) will be randomised 1:1 to outpatient CTCA plus standard of care or standard of care alone. The primary endpoint is myocardial infarction or cardiac death. Secondary endpoints include clinical, patient-centred, process and cost-effectiveness. Recruitment of 2270 patients will give 90% power with a two-sided P value of 0.05 to detect a 40% relative risk reduction in the primary endpoint. Follow-up will continue until 97 primary outcome events have been accrued in the standard care arm with an estimated median follow-up of 36 months.
Discussion
This randomised controlled trial will determine whether high-sensitivity cardiac troponin-guided CTCA can improve outcomes and reduce subsequent major adverse cardiac events in patients presenting to the emergency department who do not have myocardial infarction.
Trial registration
ClinicalTrials.gov Identifier: NCT03952351. Registered on May 16, 2019.
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Details
; Lowe, David 2 ; O’Brien, Rachel 3 ; Wereski, Ryan 1 ; Bularga, Anda 1 ; Taggart, Caelan 1 ; Lowry, Matthew T. H. 1 ; Ferry, Amy V. 1 ; Williams, Michelle C. 1 ; Roditi, Giles 4 ; Byrne, John 5 ; Tuck, Chris 1 ; Cranley, Denise 6 ; Thokala, Praveen 7 ; Goodacre, Steve 7 ; Keerie, Catriona 6 ; Norrie, John 6 ; Newby, David E. 1 ; Gray, Alasdair J. 8 ; Mills, Nicholas L. 9 1 University of Edinburgh, BHF Centre for Cardiovascular Science, Edinburgh, UK (GRID:grid.4305.2) (ISNI:0000 0004 1936 7988)
2 Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Department of Emergency Medicine, Glasgow, UK (GRID:grid.511123.5) (ISNI:0000 0004 5988 7216)
3 Royal Infirmary of Edinburgh, Department of Emergency Medicine, Emergency Medicine Research Group, Edinburgh, UK (GRID:grid.418716.d) (ISNI:0000 0001 0709 1919)
4 Glasgow University, Institute of Cardiovascular and Medical Sciences, Glasgow, UK (GRID:grid.8756.c) (ISNI:0000 0001 2193 314X)
5 Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Department of Cardiology, Glasgow, UK (GRID:grid.511123.5) (ISNI:0000 0004 5988 7216)
6 University of Edinburgh, Edinburgh Clinical Trials Unit, Usher Institute, Edinburgh, UK (GRID:grid.4305.2) (ISNI:0000 0004 1936 7988)
7 University of Sheffield, School of Health and Related Research (ScHARR), Sheffield, UK (GRID:grid.11835.3e) (ISNI:0000 0004 1936 9262)
8 Royal Infirmary of Edinburgh, Department of Emergency Medicine, Emergency Medicine Research Group, Edinburgh, UK (GRID:grid.418716.d) (ISNI:0000 0001 0709 1919); University of Edinburgh, Usher Institute of Population Health Sciences and Informatics, Edinburgh, UK (GRID:grid.4305.2) (ISNI:0000 0004 1936 7988)
9 University of Edinburgh, BHF Centre for Cardiovascular Science, Edinburgh, UK (GRID:grid.4305.2) (ISNI:0000 0004 1936 7988); University of Edinburgh, Usher Institute of Population Health Sciences and Informatics, Edinburgh, UK (GRID:grid.4305.2) (ISNI:0000 0004 1936 7988)




