用于排除与血流动力学相关的成人冠状动脉异常的无创解剖评估 - 冠状动脉 CT 与有创冠状动脉造影的比较:NARCO 研究设计

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-11-19 DOI:10.1016/j.conctc.2024.101394
Marius R. Bigler , Anselm W. Stark , Isaac Shiri , Joel Illi , Matthias Siepe , Federico Caobelli , Andreas A. Giannopoulos , Ronny R. Buechel , Andreas Haeberlin , Dominik Obrist , Lorenz Räber , Christoph Gräni
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引用次数: 0

摘要

背景冠状动脉主动脉起源异常(AAOCA)是一种罕见的先天性心脏病,可能导致心肌缺血和不良心脏事件。由于仅存在 AAOCA 并不意味着一定要进行血管重建,因此详细的解剖和功能分析对临床决策至关重要。目前,有创冠状动脉造影术是对 AAOCA 进行全面血液动力学评估的黄金标准方法。方法在 NARCO 试验中,AAOCA 患者将接受冠状动脉计算机断层扫描(CCTA),以评估解剖学上的高危特征,然后进行基于血管(即多巴酚丁胺容量挑战下的有创测量、分数血流储备和血管内成像)和基于心肌(即核成像)的缺血测试。将对无创和有创成像进行比较。此外,还将对后处理高级计算流体动力学(CFD)和三维打印进行探索性分析,以揭示 AAOCA 患者心肌缺血的病理生理机制。结论NARCO试验将有助于优化AAOCA患者的血管再通选择,改善风险分层和无创排除血流动力学相关性,从而避免对AAOCA患者进行不必要的下游检测和/或昂贵的干预。
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Noninvasive anatomical assessment for ruling out hemodynamically relevant coronary artery anomalies in adults – A comparison of coronary-CT to invasive coronary angiography: The NARCO study design

Background

Anomalous aortic origin of a coronary artery (AAOCA) is a rare congenital heart disease, potentially leading to myocardial ischemia and adverse cardiac events. As the sole presence of AAOCA does not always imply a revascularization, a detailed anatomical and functional analysis is crucial for clinical decision-making. Currently, invasive coronary angiography is the gold-standard method for a thorough hemodynamic assessment of AAOCA. However, due to its invasive nature, the development of noninvasive diagnostic alternatives is desired.

Methods

In the NARCO trial, patients with AAOCA will undergo coronary computed tomography angiography (CCTA) to assess anatomical high-risk features followed by a vessel-based (i.e. invasive measurement with fractional flow reserve and intravascular imaging under a dobutamine-volume challenge) and a myocardium-based (i.e. nuclear imaging) ischemia testing. Comparison of noninvasive and invasive imaging will be performed. Additionally, explorative analysis of post-processing advanced computational fluid dynamics (CFD) and 3D printing will be performed to unravel the pathophysiologic mechanism of myocardial ischemia in AAOCA.

Aims

Our primary aim is to define characteristics of anatomical high-risk features (using CCTA) to rule out noninvasively hemodynamically relevant anomalous vessels in AAOCA patients. The secondary aim is to investigate the underlying pathophysiology of AAOCA-related hemodynamic relevance using advanced techniques such as CFD and 3D printing.

Conclusions

The NARCO trial will help to optimize AAOCA patient selection for revascularization by improving risk stratification and ruling out hemodynamic relevance noninvasively and, therefore, preventing unnecessary downstream testing and/or costly interventions in patients with AAOCA.
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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