ECAD: Enhanced Coronary Artery Disease Phantom for MRA

由于缺乏真实的跳动心脏血流模型，建立MRA临床实用性的努力受到阻碍。我们建议开发一种增强型冠状动脉疾病（eCAD）体模，供MR研究人员和开发人员使用。eCAD将现有技术的功能与先进的设计、材料和工艺相结合，以创建一个可再现临床条件的受控环境。这将通过以下方式实现：1）基于图像数据开发功能性心脏结构，2）将结构与先进材料和处理相结合，以再现心脏功能，以及3）通过验证eCAD在解剖学上的准确性以及在脉动条件下的适当流动模式和运动来建立概念验证。创新方面包括基于临床影像信息的设计、与MRI特性兼容的组织模拟材料、心壁和冠状动脉的真实运动、超过一年的可靠性等。第一阶段开发的技术将支持额外的心脏结构和可变的壁弹性。在第二阶段，我们专注于优化组件材料和程序，以期为第三阶段临床试验构建先进的流动模型。商用eCAD对于开发、验证和培训医务人员使用最先进的冠状动脉疾病MRA诊断协议至关重要。拟议的商业应用：临床上对无创方法的需求量很大，以识别处于风险中的患者并进行冠状动脉手术，并且足够的MRI工具的商业可用性非常有限，从而为针对冠状动脉疾病的高度先进的拟人流动体模创造了有利可图的市场利基。该项目开发的产品将满足临床研究、质量保证和人员培训应用的当前和未来需求。

Efforts to establish MRA as clinically practical are hampered by lack of realistic beating heart flow phantoms. We propose to develop an enhanced Coronary Artery Disease (eCAD) phantom for use by MR researchers and developers. eCAD combines features from existing technologies with advanced design, materials and processing to create a controlled environment which reproduces clinical conditions. This will be accomplished by: 1) developing functional cardiac structures based on image data, 2) combining structures with advanced materials and processing to reproduce cardiac functionality and 3) establishing proof- of-concept by verifying that eCAD is anatomically accurate with proper flow patterns and motion under pulsatile conditions. Innovative aspects include designs based on clinical image information, tissue mimicking materials compatible with MRI characteristics, realistic motion of cardiac wall and coronary arteries, and reliability exceeding one year. Technology developed in Phase I will support the additional cardiac structures and variable wall elasticity. In Phase II, we focus on optimizing component materials and procedures in anticipation of constructing advanced flow phantoms for Phase III clinical trials. A commercially available eCAD will be critical for the development, validation and training of medical personnel on using state of the art MRA diagnostic protocols for coronary artery disease. PROPOSED COMMERCIAL APPLICATIONS: The magnitude of the clinical need for a non invasive means to identify patients at risk and stage coronary artery surgery is so large and the commercial availability of adequate MRI tools so limited as to create a lucrative market niche for highly advanced anthropomorphic flow phantoms targeted at coronary artery disease. Products developed from this project will address current and future needs in clinical research, QA, and personnel training applications.