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超低剂量胸部CT联合迭代重建术替代心脏手术前传统胸部X线检查(CRICKET研究):一项多中心随机试验的原理与设计

Ultra low-dose chest ct with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery (CRICKET study): Rationale and design of a multicenter randomized trial.

作者信息

den Harder Annemarie M, de Heer Linda M, Maurovich-Horvat Pal, Merkely Bela, de Jong Pim A, Das Marco, de Wit G Ardine, Leiner Tim, Budde Ricardo P J

机构信息

Department of Radiology, University Medical Center, P.O. Box 85000, 3508GA Utrecht, The Netherlands.

Department of Cardiothoracic Surgery, University Medical Center, P.O. Box 85000, 3508GA Utrecht, The Netherlands.

出版信息

J Cardiovasc Comput Tomogr. 2016 May-Jun;10(3):242-5. doi: 10.1016/j.jcct.2016.01.016. Epub 2016 Jan 30.

Abstract

BACKGROUND

Stroke after cardiac surgery is a severe complication with a persistently high incidence of 1.4 - 9.7%. Postoperative strokes are mainly embolic and can be provoked by manipulation and clamping of the aorta during cardiac surgery, resulting in the mobilization of atherothrombotic material and calcifications from the aortic wall. Computed tomography (CT) can offer preoperative visualization of aortic calcifications with low radiation exposure. We hypothesize that preoperative knowledge regarding the location and extent of aortic calcifications can be used to optimize surgical strategy and decrease postoperative stroke rate.

METHODS/DESIGN: The CRICKET study (ultra low-dose chest CT with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery) is a prospective multicenter randomized clinical trial to evaluate whether non-contrast chest CT before cardiac surgery can decrease postoperative stroke rate by optimizing surgical strategy. Patients scheduled to undergo cardiac surgery aged 18 years and older are eligible for inclusion. Exclusion criteria are pregnancy, a chest/cardiac CT in the past three months, emergency surgery, concomitant or prior participation in a study with ionizing radiation and unwillingness to be informed about incidental findings. Subjects (n = 1.724) are randomized between routine care, including a chest x-ray, or routine care with an additional low dose chest CT. The primary objective is to investigate whether the postoperative in-hospital stroke rate is reduced in the CT arm compared to the routine care arm of the randomized trial. The secondary outcome measures are altered surgical approach based on CT findings and cost-effectiveness.

摘要

背景

心脏手术后的中风是一种严重并发症,发病率持续居高不下,为1.4%-9.7%。术后中风主要为栓塞性,可能由心脏手术期间主动脉的操作和夹闭引发,导致动脉粥样硬化血栓物质和主动脉壁钙化的移动。计算机断层扫描(CT)能够以低辐射剂量提供主动脉钙化的术前可视化影像。我们推测,关于主动脉钙化位置和范围的术前信息可用于优化手术策略并降低术后中风发生率。

方法/设计:CRICKET研究(心脏手术前采用迭代重建的超低剂量胸部CT替代传统胸部X光检查)是一项前瞻性多中心随机临床试验,旨在评估心脏手术前的非增强胸部CT是否可通过优化手术策略降低术后中风发生率。计划接受心脏手术、年龄在18岁及以上的患者符合纳入标准。排除标准包括妊娠、过去三个月内进行过胸部/心脏CT检查、急诊手术、同时或此前参与过电离辐射相关研究以及不愿了解偶然发现。受试者(n = 1724)被随机分为接受包括胸部X光检查的常规护理组或接受额外低剂量胸部CT检查的常规护理组。主要目标是研究与随机试验的常规护理组相比,CT组的术后住院中风发生率是否降低。次要结局指标包括基于CT检查结果改变手术方式以及成本效益。

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