Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.
Villa Mafalda Clinical Institute, Rome, Italy.
Sci Rep. 2019 Sep 25;9(1):13872. doi: 10.1038/s41598-019-50407-6.
We performed a pilot randomised study to assess the feasibility and radiation exposure of a new computed tomography (CT) protocol that allows screening of both coronary artery disease (CAD) and lung cancer. Current or former heavy smokers at high lung cancer risk with indication to cardiac CT for suspected or known CAD were randomised to undergo concomitant CT evaluation of either cardiac or thoracic area or cardiac CT only. Out of 129 subjects deemed eligible for the study, 110 agreed to participate and were randomised to simultaneous cardiac and lung CT (Gr.A; n = 55) or cardiac CT only (Gr.B; n = 55). The feasibility (i.e. adequate visualization of coronary artery segments) was noninferior with simultaneous cardiac and lung CT compared with the standard cardiac CT (870 of 889 segments [97%] in Gr.A vs 878/890 segments [99%] in Gr.B; mean difference 2.0% [90% confidence interval: -0.3% to 4.1%]). The safety (i.e. effective radiation dose) of the concomitant cardiac and lung CT protocol was noninferior to the standard cardiac CT (1.5 [95% confidence intervals: 1.2-1.7] vs. 1.4 [95% confidence intervals: 1.1-1.6] mSv; mean difference 0.1 mSv [90% confidence interval: -0.2 to 0.3 mSv]). In the two groups, a total of 25 significant (>70%) coronary stenoses were found at cardiac CT (9/55 cases of Gr.A vs 11/55 cases of Gr.B). Pulmonary nodules >2 mm were detected in 7 of the 55 Gr.A subjects. This pilot randomised study shows that concomitant CAD and lung cancer screening by means of a new CT protocol is both feasible and safe, thus allowing a comprehensive evaluation of both cardiac and thoracic regions during one CT scanning only. (ClinicalTrials.gov Identifier: NCT03727958).
我们进行了一项初步的随机研究,以评估一种新的计算机断层扫描(CT)方案的可行性和辐射暴露,该方案可同时筛查冠心病(CAD)和肺癌。有肺癌高风险的当前或既往重度吸烟者,且因疑似或已知 CAD 而行心脏 CT 检查,他们被随机分为同时评估心脏或胸部区域或仅行心脏 CT。在符合研究条件的 129 名患者中,有 110 名同意参与,并被随机分为同时进行心脏和肺部 CT(Gr.A;n=55)或仅行心脏 CT(Gr.B;n=55)。同时进行心脏和肺部 CT 的可行性(即冠状动脉节段的充分可视化)与标准心脏 CT 相比不劣(Gr.A 组中 870/889 个节段[97%]与 Gr.B 组中 878/890 个节段[99%];平均差异 2.0%[90%置信区间:-0.3%至 4.1%])。同时进行心脏和肺部 CT 方案的安全性(即有效辐射剂量)与标准心脏 CT 相比不劣(1.5[95%置信区间:1.2-1.7]vs.1.4[95%置信区间:1.1-1.6]mSv;平均差异 0.1 mSv[90%置信区间:-0.2 至 0.3 mSv])。在两组中,心脏 CT 共发现 25 处有意义的(>70%)冠状动脉狭窄(Gr.A 组 9/55 例,Gr.B 组 11/55 例)。Gr.A 组 55 例中有 7 例检测到 >2mm 的肺结节。这项初步随机研究表明,通过新的 CT 方案同时筛查 CAD 和肺癌是可行且安全的,因此仅在一次 CT 扫描中即可对心脏和胸部区域进行全面评估。(临床试验注册号:NCT03727958)