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意大利多中心前瞻性研究,旨在评估16层和64层MDCT成像对计划进行冠状动脉造影患者的阴性预测价值(NIMISCAD-意大利冠状动脉疾病非侵入性多中心研究)。

Italian multicenter, prospective study to evaluate the negative predictive value of 16- and 64-slice MDCT imaging in patients scheduled for coronary angiography (NIMISCAD-Non Invasive Multicenter Italian Study for Coronary Artery Disease).

作者信息

Marano Riccardo, De Cobelli Francesco, Floriani Irene, Becker Christoph, Herzog Christopher, Centonze Maurizio, Morana Giovanni, Gualdi Gian Franco, Ligabue Guido, Pontone Gianluca, Catalano Carlo, Chiappino Dante, Midiri Massimo, Simonetti Giovanni, Marchisio Filippo, Olivetti Lucio, Fattori Rossella, Bonomo Lorenzo, Del Maschio Alessandro

机构信息

Department of Bioimaging and Radiological Sciences, Institute of Radiology, A. Gemelli Hospital - Catholic University, L.go A Gemelli 8, 00168 Rome, Italy.

出版信息

Eur Radiol. 2009 May;19(5):1114-23. doi: 10.1007/s00330-008-1239-8. Epub 2008 Dec 17.

DOI:10.1007/s00330-008-1239-8
PMID:19089430
Abstract

This was a prospective, multicenter study designed to evaluate the utility of MDCT in the diagnosis of coronary artery disease (CAD) in patients scheduled for elective coronary angiography (CA) using different MDCT systems from different manufacturers. Twenty national sites prospectively enrolled 367 patients between July 2004 and June 2006. Computed tomography (CT) was performed using a standardized/optimized scan protocol for each type of MDCT system (> or =16 slices) and compared with quantitative CA performed within 2 weeks of MDCT. A total of 284 patients (81%) were studied by 16-slice MDCT systems, while 66 patients (19%) by 64-slice MDCT scanners. The primary analysis was on-site/off-site evaluation of the negative predictive value (NPV) on a per-patient basis. Secondary analyses included on-site evaluation on a per-artery and per-segment basis. On-site evaluation included 327 patients (CAD prevalence 58%). NPV, positive predictive value (PPV), sensitivity, specificity, and diagnostic accuracy (DA) were 0.91 (95% CI 0.85-0.95), 0.91 (95% CI 0.86-0.95), 0.94 (95% CI 0.89-0.97), 0.88 (95% CI 0.81-0.93), and 0.91 (95% CI 0.88-0.94), respectively. Off-site analysis included 295 patients (CAD prevalence 56%). NPV, PPV, sensitivity, specificity, and DA were 0.73 (95% CI 0.65-0.79), 0.93 (95% CI 0.87-0.97), 0.73 (95% CI 0.65-0.79), 0.93 (95% CI 0.87-0.97), and 0.82 (95% CI 0.77-0.86), respectively. The results of this study demonstrate the utility of MDCT in excluding significant CAD even when conducted by centers with varying degrees of expertise and using different MDCT machines.

摘要

这是一项前瞻性多中心研究,旨在评估多排螺旋CT(MDCT)在计划接受选择性冠状动脉造影(CA)的患者中诊断冠状动脉疾病(CAD)的效用,这些患者使用来自不同制造商的不同MDCT系统。20个国家的研究点在2004年7月至2006年6月期间前瞻性纳入了367例患者。针对每种类型的MDCT系统(≥16层)使用标准化/优化的扫描方案进行计算机断层扫描(CT),并与在MDCT检查后2周内进行的定量CA进行比较。共有284例患者(81%)接受了16层MDCT系统检查,而66例患者(19%)接受了64层MDCT扫描仪检查。主要分析是基于每位患者的现场/非现场阴性预测值(NPV)评估。次要分析包括基于每条动脉和每段血管的现场评估。现场评估包括327例患者(CAD患病率为58%)。NPV、阳性预测值(PPV)、敏感性、特异性和诊断准确性(DA)分别为0.91(95%CI 0.85 - 0.95)、0.91(95%CI 0.86 - 0.95)、0.94(95%CI 0.89 - 0.97)、0.88(95%CI 0.81 - 0.93)和0.91(95%CI 0.88 - 0.94)。非现场分析包括295例患者(CAD患病率为56%)。NPV、PPV、敏感性、特异性和DA分别为0.73(95%CI 0.65 - 0.79)、0.93(95%CI 0.87 - 0.97)、0.73(95%CI 0.65 - 0.79)、0.93(95%CI 0.87 - 0.97)和0.82(95%CI 0.77 - 0.86)。这项研究的结果表明,即使由专业程度不同的中心使用不同的MDCT机器进行检查,MDCT在排除显著CAD方面也是有用的。

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