旁路CTCA研究：计算机断层扫描心脏血管造影（CTCA）在改善既往接受旁路手术的患者进行有创冠状动脉血管造影时与患者相关结局方面的价值：一项随机对照试验的研究方案
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.
作者信息
Beirne Anne-Marie, Rathod Krishnaraj S, Castle Emily, Andiapen Mervyn, Richards Amy, Bellin Anna, Hammond Victoria, Godec Thomas, Moon James C, Davies Ceri, Bourantas Christos V, Wragg Andrew, Ahluwalia Amrita, Pugliese Francesca, Mathur Anthony, Jones Daniel A
机构信息
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.
出版信息
Ann Transl Med. 2021 Sep;9(17):1395. doi: 10.21037/atm-21-1455.
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.
背景
患有缺血性心脏病且既往接受过冠状动脉旁路移植术（CABG）的患者通常需要通过有创冠状动脉造影（ICA）进行冠状动脉评估。此类患者的 ICA 在技术上更具挑战性，且发生并发症的风险更高，包括肾损伤、心肌梗死、中风和死亡。计算机断层扫描心脏血管造影（CTCA）技术的改进已确保其成为 CABG 评估中一种有用的临床工具，使其有可能用于该患者群体的介入手术规划。
方法
BYPASS - CTCA 研究是一项前瞻性、单中心、随机对照试验，评估术前 CTCA 对既往接受手术血运重建并需进行 ICA 手术的患者的价值。总共将招募 688 例既往接受 CABG 且因标准适应症需要进行 ICA 的患者，并随机分为仅接受 ICA 组或在血管造影术前接受 CTCA 组。术后对受试者进行为期 12 个月的随访。主要终点为 ICA 手术持续时间、造影剂诱发肾病（CIN）的发生率以及 ICA 术后患者满意度评分。次要终点包括 ICA 期间的造影剂剂量（毫升）和辐射剂量（毫西弗）、使用的导管数量、血管造影相关并发症以及 CTCA 在 12 个月内的成本效益（质量调整生命年）。
讨论
该研究将调查以下假设，即既往接受 CABG 的患者在 ICA 术前进行 CTCA 可缩短手术持续时间、减少术后肾损伤并提高患者满意度，从而强化其在该患者群体中的作用。
试验注册
该研究已在 ClinicalTrials.gov 上注册，ClinicalTrials.gov 是美国国立医学图书馆维护的一个资源。注册号为 NCT03736018。
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