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Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial
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 troponi...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10264092/ https://www.ncbi.nlm.nih.gov/pubmed/37312104 http://dx.doi.org/10.1186/s13063-023-07431-9 |
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author | Lee, Kuan Ken Lowe, David O’Brien, Rachel Wereski, Ryan Bularga, Anda Taggart, Caelan Lowry, Matthew T. H. Ferry, Amy V. Williams, Michelle C. Roditi, Giles Byrne, John Tuck, Chris Cranley, Denise Thokala, Praveen Goodacre, Steve Keerie, Catriona Norrie, John Newby, David E. Gray, Alasdair J. Mills, Nicholas L. |
author_facet | Lee, Kuan Ken Lowe, David O’Brien, Rachel Wereski, Ryan Bularga, Anda Taggart, Caelan Lowry, Matthew T. H. Ferry, Amy V. Williams, Michelle C. Roditi, Giles Byrne, John Tuck, Chris Cranley, Denise Thokala, Praveen Goodacre, Steve Keerie, Catriona Norrie, John Newby, David E. Gray, Alasdair J. Mills, Nicholas L. |
author_sort | Lee, Kuan Ken |
collection | PubMed |
description | 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07431-9. |
format | Online Article Text |
id | pubmed-10264092 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-102640922023-06-14 Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial Lee, Kuan Ken Lowe, David O’Brien, Rachel Wereski, Ryan Bularga, Anda Taggart, Caelan Lowry, Matthew T. H. Ferry, Amy V. Williams, Michelle C. Roditi, Giles Byrne, John Tuck, Chris Cranley, Denise Thokala, Praveen Goodacre, Steve Keerie, Catriona Norrie, John Newby, David E. Gray, Alasdair J. Mills, Nicholas L. Trials Study Protocol 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07431-9. BioMed Central 2023-06-13 /pmc/articles/PMC10264092/ /pubmed/37312104 http://dx.doi.org/10.1186/s13063-023-07431-9 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Lee, Kuan Ken Lowe, David O’Brien, Rachel Wereski, Ryan Bularga, Anda Taggart, Caelan Lowry, Matthew T. H. Ferry, Amy V. Williams, Michelle C. Roditi, Giles Byrne, John Tuck, Chris Cranley, Denise Thokala, Praveen Goodacre, Steve Keerie, Catriona Norrie, John Newby, David E. Gray, Alasdair J. Mills, Nicholas L. Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial |
title | Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial |
title_full | Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial |
title_fullStr | Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial |
title_full_unstemmed | Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial |
title_short | Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial |
title_sort | troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (target-ctca): a randomised controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10264092/ https://www.ncbi.nlm.nih.gov/pubmed/37312104 http://dx.doi.org/10.1186/s13063-023-07431-9 |
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