The BYPASS-CTCA Study: the value of Computed Tomography Cardiac Angiography (CTCA) in improving patient-related outcomes in patients with previous bypass operation undergoing invasive coronary angiography: Study Protocol of a Randomised Controlled Trial.

Autor:	Beirne AM; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.; Barts Interventional Group, Barts Heart Centre, Barts Health NHS Trust, London, UK.; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK., Rathod KS; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.; Barts Interventional Group, Barts Heart Centre, Barts Health NHS Trust, London, UK.; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK., Castle E; Department of Cardiac Imaging, Barts Heart Centre, Barts Health NHS Trust, London, UK., Andiapen M; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.; Barts Interventional Group, Barts Heart Centre, Barts Health NHS Trust, London, UK.; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK., Richards A; Barts Interventional Group, Barts Heart Centre, Barts Health NHS Trust, London, UK.; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK., Bellin A; Barts Cardiovascular Clinical Trials Unit, Queen Mary University of London, London, UK., Hammond V; Barts Cardiovascular Clinical Trials Unit, Queen Mary University of London, London, UK., Godec T; Barts Cardiovascular Clinical Trials Unit, Queen Mary University of London, London, UK., Moon JC; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK.; Department of Cardiac Imaging, Barts Heart Centre, Barts Health NHS Trust, London, UK., Davies C; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK.; Department of Cardiac Imaging, Barts Heart Centre, Barts Health NHS Trust, London, UK., Bourantas CV; Barts Interventional Group, Barts Heart Centre, Barts Health NHS Trust, London, UK.; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK., Wragg A; Barts Interventional Group, Barts Heart Centre, Barts Health NHS Trust, London, UK.; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK., Ahluwalia A; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK.; Barts Cardiovascular Clinical Trials Unit, Queen Mary University of London, London, UK., Pugliese F; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK.; Department of Cardiac Imaging, Barts Heart Centre, Barts Health NHS Trust, London, UK., Mathur A; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.; Barts Interventional Group, Barts Heart Centre, Barts Health NHS Trust, London, UK.; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK., Jones DA; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK.; Barts Interventional Group, Barts Heart Centre, Barts Health NHS Trust, London, UK.; NIHR Barts Biomedical Research Centre, Barts Heart Centre and William Harvey Research Institute, Queen Mary University of London, London, UK.; Barts Cardiovascular Clinical Trials Unit, Queen Mary University of London, London, UK.
Jazyk:	angličtina
Zdroj:	Annals of translational medicine [Ann Transl Med] 2021 Sep; Vol. 9 (17), pp. 1395.
DOI:	10.21037/atm-21-1455
Abstrakt:	Background: Patients with ischaemic heart disease and previous coronary artery bypass grafting (CABG) often need coronary evaluation by means of invasive coronary angiography (ICA). ICA in such patients is technically more challenging and carries a higher risk of complications including kidney damage, myocardial infarction, stroke and death. Improvements in Computed Tomography Cardiac Angiography (CTCA) technology have ensured its emergence as a useful clinical tool in CABG assessment, allowing for its potential use in planning interventional procedures in this patient group. Methods: The BYPASS-CTCA study is a prospective, single centre, randomised controlled trial assessing the value of upfront CTCA in patients with previous surgical revascularisation undergoing ICA procedures. A total of 688 patients with previous CABG, requiring ICA for standard indications, will be recruited and randomised to receive ICA alone, or CTCA prior to angiography. Subjects will be followed up over a 12-month period post procedure. The primary endpoints are ICA procedural duration, incidence of contrast-induced nephropathy (CIN) and patient satisfaction scores post ICA. Secondary endpoints include contrast dose (mL) and radiation dose (mSv) during ICA, number of catheters used, angiography-related complications and cost-effectiveness of CTCA (QALY) over 12 months. Discussion: The study will investigate the hypothesis that CTCA prior to ICA in patients with previous CABG can reduce procedural duration, post-procedural kidney damage and improve patient satisfaction, therefore strengthening its role in this group of patients. Trial Registration: The study is registered on ClinicalTrials.gov which is a resource maintained by the U.S. National Library of Medicine. Registration number NCT03736018. Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://dx.doi.org/10.21037/atm-21-1455). FP reports receiving institutional research support from Siemens Healthineers. The other authors have no conflicts of interest to declare. (2021 Annals of Translational Medicine. All rights reserved.)
Databáze:	MEDLINE
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