Morristown Medical Center, Morristown, New Jersey.
Centre for Heart Valve Innovation UBC, Vancouver, British Columbia, Canada.
JACC Cardiovasc Imaging. 2017 Mar;10(3):296-303. doi: 10.1016/j.jcmg.2016.12.003.
Cardiovascular imaging is an integral component of many clinical trials beyond those for which the primary goal is to evaluate or validate imaging technologies. The scope of such trials is broad, ranging from those in which a medical, surgical, or interventional cardiovascular device or drug is being evaluated to those in which there is concern about cardiovascular adverse events complicating treatment for noncardiac conditions. This paper discusses study design as it pertains to the incorporation of imaging elements, the important role played by imaging core laboratories, the rationale for and approaches to involvement of imagers in clinical trials, and guidance by the U.S. Food and Drug Administration on imaging endpoints in clinical trials.
心血管影像在许多临床试验中是一个不可或缺的部分，这些临床试验的主要目的不仅是评估或验证影像技术。此类试验的范围很广，从评估医疗、外科或介入心血管设备或药物的试验，到关注因非心脏疾病治疗而导致心血管不良事件的试验。本文讨论了与影像元素纳入相关的研究设计、影像核心实验室的重要作用、影像医师参与临床试验的原理和方法，以及美国食品和药物管理局对临床试验中影像终点的指导。
