INVICTUS 注册研究的原理和设计：（一项多中心注册研究，旨在比较侵入性和非侵入性成像方式，以确定冠状动脉粥样硬化的严重程度、体积和类型）。
Rationale and design of the INVICTUS Registry: (Multicenter Registry of Invasive and Non-Invasive imaging modalities to compare Coronary Computed Tomography Angiography, Intravascular Ultrasound and Optical Coherence Tomography for the determination of Severity, Volume and Type of coronary atherosclerosiS).
机构信息
Department of Cardiovascular Medicine, Toho University Graduate School of Medicine, Toho University Omori Medical Center, Tokyo, Japan.
Division of Cardiovascular Medicine, Department of Internal Medicine, Toho University Faculty of Medicine, Toho University Omori Medical Center, Tokyo, Japan.
出版信息
J Cardiovasc Comput Tomogr. 2023 Nov-Dec;17(6):401-406. doi: 10.1016/j.jcct.2023.08.011. Epub 2023 Sep 9.
BACKGROUND
Coronary CT angiography (CCTA) is a first-line noninvasive imaging modality for evaluating coronary artery disease (CAD). Recent advances in CCTA technology enabled semi-automated detection of coronary arteries and atherosclerosis. However, there have been to date no large-scale validation studies of automated assessment of coronary atherosclerosis phenotype and coronary artery dimensions by artificial intelligence (AI) compared to current standard invasive imaging.
METHODS
INVICTUS registry is a multicenter, retrospective, and prospective study designed to evaluate the dimensions of coronary arteries, as well as the characteristic, volume, and phenotype of coronary atherosclerosis by CCTA, compared with the invasive imaging modalities including intravascular ultrasound (IVUS), near-infrared spectroscopy (NIRS)-IVUS and optical coherence tomography (OCT). All patients clinically underwent both CCTA and invasive imaging modalities within three months.
RESULTS
Patients data are sent to the core-laboratories to analyze for stenosis severity, plaque characteristics and volume. The variables for CCTA are measured using an AI-based automated software and assessed independently with the variables measured at the imaging core laboratories for IVUS, NIRS-IVUS, and OCT in a blind fashion.
CONCLUSION
The INVICTUS registry will provide new insights into the diagnostic value of CCTA for determining coronary atherosclerosis phenotype and coronary artery dimensions compared to IVUS, NIRS-IVUS, and OCT. Our findings will potentially shed new light on precision medicine informed by an AI-based coronary CTA assessment of coronary atherosclerosis burden, composition, and severity. (ClinicalTrials.gov: NCT04066062).
背景
冠状动脉 CT 血管造影（CCTA）是评估冠状动脉疾病（CAD）的一线无创影像学方法。CCTA 技术的最新进展使得冠状动脉和动脉粥样硬化的半自动检测成为可能。然而，迄今为止，与当前标准的有创成像相比，还没有关于人工智能（AI）自动评估冠状动脉粥样硬化表型和冠状动脉尺寸的大型验证研究。
方法
INVICTUS 注册研究是一项多中心、回顾性和前瞻性研究，旨在通过 CCTA 评估冠状动脉的尺寸以及冠状动脉粥样硬化的特征、体积和表型，并与包括血管内超声（IVUS）、近红外光谱-IVUS（NIRS-IVUS）和光学相干断层扫描（OCT）在内的有创成像方式进行比较。所有患者在三个月内均同时进行 CCTA 和有创成像方式检查。
结果
将患者数据发送到核心实验室，以分析狭窄严重程度、斑块特征和体积。使用基于 AI 的自动软件测量 CCTA 的变量，并以盲法独立评估与 IVUS、NIRS-IVUS 和 OCT 成像核心实验室测量的变量。
结论
INVICTUS 注册研究将提供新的见解，了解与 IVUS、NIRS-IVUS 和 OCT 相比，CCTA 对确定冠状动脉粥样硬化表型和冠状动脉尺寸的诊断价值。我们的发现可能为基于 AI 的冠状动脉 CTA 评估冠状动脉粥样硬化负担、成分和严重程度的精准医学提供新的思路。（临床试验.gov：NCT04066062）。
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