OBJECTIVE To implement detailed EU cardiac computed tomography angiography (CCTA) quality criteria in the multicentre DISCHARGE trial (FP72007-2013, EC-GA 603266), we reviewed image quality and adherence to CCTA protocol and to the recommendations of invasive coronary angiography (ICA) in a pilot study. MATERIALS AND METHODS From every clinical centre, imaging datasets of three patients per arm were assessed for adherence to the inclusion/exclusion criteria of the pilot study, predefined standards for the CCTA protocol and ICA recommendations, image quality and non-diagnostic (NDX) rate. These parameters were compared via multinomial regression and ANOVA. If a site did not reach the minimum quality level, additional datasets had to be sent before entering into the final accepted database (FADB). RESULTS We analysed 226 cases (150 CCTA/76 ICA). The inclusion/exclusion criteria were not met by 6 of the 226 (2.7%) datasets. The predefined standard was not met by 13 of 76 ICA datasets (17.1%). This percentage decreased between the initial CCTA database and the FADB (multinomial regression, 53 of 70 vs 17 of 75 [76%] vs [23%]). The signal-to-noise ratio and contrast-to-noise ratio of the FADB did not improve significantly (ANOVA, p = 0.20; p = 0.09). The CTA NDX rate was reduced, but not significantly (initial CCTA database 15 of 70 [21.4%]) and FADB 9 of 75 [12%]; p = 0.13). CONCLUSION We were able to increase conformity to the inclusion/exclusion criteria and CCTA protocol, improve image quality and decrease the CCTA NDX rate by implementing EU CCTA quality criteria and ICA recommendations. KEY POINTS • Failure to meet protocol adherence in cardiac CTA was high in the pilot study (77.6%). • Image quality varies between sites and can be improved by feedback given by the core lab. • Conformance with new EU cardiac CT quality criteria might render cardiac CTA findings more consistent and comparable.

中文翻译：

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多中心 DISCHARGE 试验的初步研究：计算机断层扫描和侵入性冠状动脉造影的图像质量和方案依从性结果。

目的 为了在多中心 DISCHARGE 试验（FP72007-2013，EC-GA 603266）中实施详细的欧盟心脏计算机断层扫描血管造影 (CCTA) 质量标准，我们审查了图像质量和对 CCTA 协议以及侵入性冠状动脉造影 (ICA) 建议的遵守情况在一项试点研究中。材料和方法 从每个临床中心，评估每组三名患者的影像数据集是否符合初步研究的纳入/排除标准、CCTA 协议和 ICA 建议的预定义标准、图像质量和非诊断 (NDX) 率. 这些参数通过多项式回归和方差分析进行比较。如果站点未达到最低质量水平，则必须在进入最终接受的数据库 (FADB) 之前发送额外的数据集。结果 我们分析了 226 个病例（150 个 CCTA/76 个 ICA）。226 个 (2.7%) 数据集中的 6 个不符合纳入/排除标准。76 个 ICA 数据集中有 13 个 (17.1%) 不符合预定义标准。这个百分比在初始 CCTA 数据库和 FADB 之间有所下降（多项式回归，70 个中的 53 个对 75 个中的 17 个 [76%] 对 [23%]）。FADB 的信噪比和对比度噪声比没有显着改善（ANOVA，p = 0.20；p = 0.09）。CTA NDX 率有所降低，但并不显着（初始 CCTA 数据库 70 中的 15 [21.4%]）和 FADB 75 中的 9 [12%]；p = 0.13）。结论 通过实施欧盟 CCTA 质量标准和 ICA 推荐，我们能够提高对纳入/排除标准和 CCTA 协议的符合性，提高图像质量并降低 CCTA NDX 率。要点 • 在初步研究中，心脏 CTA 未能满足方案依从性的情况很严重 (77. 6%)。• 图像质量因站点而异，可以通过核心实验室提供的反馈进行改进。• 符合新的欧盟心脏CT 质量标准可能会使心脏CTA 结果更加一致和可比。