Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
Image Sciences Institute, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
BMJ Open. 2019 Mar 1;9(3):e025793. doi: 10.1136/bmjopen-2018-025793.
Anatomic stenosis evaluation on coronary CT angiography (CCTA) lacks specificity in indicating the functional significance of a stenosis. Recent developments in CT techniques (including dual-layer spectral detector CT [SDCT] and static stress CT perfusion [CTP]) and image analyses (including fractional flow reserve [FFR] derived from CCTA images [FFR] and deep learning analysis [DL]) are potential strategies to increase the specificity of CCTA by combining both anatomical and functional information in one investigation. The aim of the current study is to assess the diagnostic performance of (combinations of) SDCT, CTP, FFR and DL for the identification of functionally significant coronary artery stenosis.
Seventy-five patients aged 18 years and older with stable angina and known coronary artery disease and scheduled to undergo clinically indicated invasive FFR will be enrolled. All subjects will undergo the following SDCT scans: coronary calcium scoring, static stress CTP, rest CCTA and if indicated (history of myocardial infarction) a delayed enhancement acquisition. Invasive FFR of ≤0.80, measured within 30 days after the SDCT scans, will be used as reference to indicate a functionally significant stenosis. The primary study endpoint is the diagnostic performance of SDCT (including CTP) for the identification of functionally significant coronary artery stenosis. Secondary study endpoint is the diagnostic performance of SDCT, CTP, FFR and DL separately and combined for the identification of functionally significant coronary artery stenosis.
Ethical approval was obtained. All subjects will provide written informed consent. Study findings will be disseminated through peer-reviewed conference presentations and journal publications.
NCT03139006; Pre-results.
冠状动脉 CT 血管造影（CCTA）的解剖学狭窄评估在指示狭窄的功能意义方面缺乏特异性。CT 技术（包括双层光谱探测器 CT [SDCT] 和静态压力 CT 灌注 [CTP]）和图像分析（包括来自 CCTA 图像的分数流量储备 [FFR] [FFR]和深度学习分析 [DL]）的最新进展是通过将解剖学和功能信息结合在一次检查中，提高 CCTA 特异性的潜在策略。本研究旨在评估（组合）SDCT、CTP、FFR 和 DL 对识别功能性冠状动脉狭窄的诊断性能。
将纳入 75 名年龄在 18 岁及以上、稳定型心绞痛且已知患有冠心病并计划进行临床指征性有创 FFR 的患者。所有患者将进行以下 SDCT 扫描：冠状动脉钙化评分、静态压力 CTP、静息 CCTA，如果有必要（心肌梗死病史）进行延迟增强采集。在 SDCT 扫描后 30 天内测量的有创 FFR ≤0.80 将作为指示功能性狭窄的参考。主要研究终点是 SDCT（包括 CTP）对功能性冠状动脉狭窄的识别诊断性能。次要研究终点是 SDCT、CTP、FFR 和 DL 单独和联合对功能性冠状动脉狭窄的识别诊断性能。
已获得伦理批准。所有患者都将提供书面知情同意书。研究结果将通过同行评审的会议演示和期刊出版物进行传播。
NCT03139006；预结果。
