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心脏磁共振临床试验的未来。

The Future of Cardiac Magnetic Resonance Clinical Trials.

作者信息

Rabbat Mark G, Kwong Raymond Y, Heitner John F, Young Alistair A, Shanbhag Sujata M, Petersen Steffen E, Selvanayagam Joseph B, Berry Colin, Nagel Eike, Heydari Bobak, Maceira Alicia M, Shenoy Chetan, Dyke Christopher, Bilchick Kenneth C

机构信息

Division of Cardiology, Loyola University Chicago, Chicago, Illinois, USA; Division of Cardiology, Edward Hines Jr VA Hospital, Hines, Illinois, USA.

Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.

出版信息

JACC Cardiovasc Imaging. 2022 Dec;15(12):2127-2138. doi: 10.1016/j.jcmg.2021.07.029. Epub 2021 Dec 15.

Abstract

Over the past 2 decades, cardiac magnetic resonance (CMR) has become an essential component of cardiovascular clinical care and contributed to imaging-guided diagnosis and management of coronary artery disease, cardiomyopathy, congenital heart disease, cardio-oncology, valvular, and vascular disease, amongst others. The widespread availability, safety, and capability of CMR to provide corresponding anatomical, physiological, and functional data in 1 imaging session can improve the design and conduct of clinical trials through both a reduction of sample size and provision of important mechanistic data that may augment clinical trial findings. Moreover, prospective imaging-guided strategies using CMR can enhance safety, efficacy, and cost-effectiveness of cardiovascular pathways in clinical practice around the world. As the future of large-scale clinical trial design evolves to integrate personalized medicine, cost-effectiveness, and mechanistic insights of novel therapies, the integration of CMR will continue to play a critical role. In this document, the attributes, limitations, and challenges of CMR's integration into the future design and conduct of clinical trials will also be covered, and recommendations for trialists will be explored. Several prominent examples of clinical trials that test the efficacy of CMR-imaging guided pathways will also be discussed.

摘要

在过去20年中,心脏磁共振成像(CMR)已成为心血管临床护理的重要组成部分,并为冠状动脉疾病、心肌病、先天性心脏病、心脏肿瘤学、瓣膜病和血管疾病等的影像引导诊断和管理做出了贡献。CMR具有广泛的可用性、安全性,并且能够在一次成像检查中提供相应的解剖、生理和功能数据,通过减少样本量以及提供可能增强临床试验结果的重要机制数据,可改善临床试验的设计和实施。此外,使用CMR的前瞻性影像引导策略可提高全球临床实践中心血管治疗途径的安全性、有效性和成本效益。随着大规模临床试验设计的未来发展,将个性化医疗、成本效益和新疗法的机制性见解纳入其中,CMR的整合将继续发挥关键作用。本文还将探讨CMR整合到未来临床试验设计和实施中的特性、局限性和挑战,并为试验人员提供相关建议。还将讨论一些测试CMR成像引导治疗途径疗效的临床试验的突出例子。

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