Shahin Yousef, Johns Christopher, Karunasaagarar Kavitasagary, Kiely David G, Swift Andy J
Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.
Department of Clinical Radiology, Sheffield Teaching Hospitals, Sheffield, UK.
Contemp Clin Trials Commun. 2019 Jul 24;15:100417. doi: 10.1016/j.conctc.2019.100417. eCollection 2019 Sep.
Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe but treatable disease that is commonly underdiagnosed. Computed tomography lung subtraction iodine mapping (CT-LSIM) in addition to standard CT pulmonary angiography (CTPA) may improve the evaluation of suspected chronic pulmonary embolism and improve the diagnostic pick up rate. We aim to recruit 100 patients suspected of having CTEPH and perform CT-LSIM scans in addition to the current gold standard test of nuclear medicine test (lung single photon emission computed tomography (SPECT) imaging) as a pilot study which will contribute to and inform the definitive trial. The diagnostic accuracy of CT-LSIM and lung SPECT will be compared. The primary outcome of the full definitive study is non-inferiority of CT-LSIM versus lung SPECT imaging.
慢性血栓栓塞性肺动脉高压(CTEPH)是一种严重但可治疗的疾病,通常诊断不足。除标准的CT肺动脉造影(CTPA)外,计算机断层扫描肺减影碘图(CT-LSIM)可能会改善对疑似慢性肺栓塞的评估,并提高诊断检出率。我们的目标是招募100名疑似患有CTEPH的患者,并除了进行当前核医学检测的金标准试验(肺单光子发射计算机断层扫描(SPECT)成像)外,还进行CT-LSIM扫描,作为一项试点研究,这将为确定性试验做出贡献并提供信息。将比较CT-LSIM和肺SPECT的诊断准确性。完整确定性研究的主要结果是CT-LSIM相对于肺SPECT成像的非劣效性。