Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial

Trials

Study Protocol

Matthew T. H. Lowry¹  Chris Tuck¹  David E. Newby¹  Anda Bularga¹  Amy V. Ferry¹  Caelan Taggart¹  Ryan Wereski¹  Kuan Ken Lee¹  Michelle C. Williams¹  Nicholas L. Mills²  John Byrne³  Rachel O’Brien⁴  Alasdair J. Gray⁵  David Lowe⁶  Denise Cranley⁷  John Norrie⁷  Catriona Keerie⁷  Giles Roditi⁸  Steve Goodacre⁹  Praveen Thokala⁹ 

[1] BHF Centre for Cardiovascular Science, University of Edinburgh, EH16 4SA, Edinburgh, UK;BHF Centre for Cardiovascular Science, University of Edinburgh, EH16 4SA, Edinburgh, UK;Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK;Department of Cardiology, Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK;Department of Emergency Medicine, Emergency Medicine Research Group, Royal Infirmary of Edinburgh, Edinburgh, UK;Department of Emergency Medicine, Emergency Medicine Research Group, Royal Infirmary of Edinburgh, Edinburgh, UK;Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK;Department of Emergency Medicine, Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK;Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK;Institute of Cardiovascular and Medical Sciences, Glasgow University, Glasgow, UK;School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK;

关键词: High-sensitivity cardiac troponin;    Computed tomography coronary angiography;    Coronary heart disease;    Acute coronary syndrome;   

DOI  :  10.1186/s13063-023-07431-9

 received in 2023-03-20, accepted in 2023-06-05,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsTARGET-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.DiscussionThis 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 registrationClinicalTrials.gov Identifier: NCT03952351. Registered on May 16, 2019.

【 授权许可】

CC BY   
© The Author(s) 2023

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