GOALI: The Assessment of Stent Effectiveness using a Wearable MEMS Microphone Array System

CBET-0828912 Akay冠状动脉疾病（CAD）是世界上主要的死亡原因之一，三分之一的死亡归因于这种疾病。据估计，全世界有600万患者接受了药物洗脱支架，这可能会造成亚急性血栓形成的潜在风险。在支架装置植入后长达一年或更长时间内可能发生再狭窄。在45%的病例中，在支架插入后这么久发生的血栓形成是致命的。 由于晚期支架血栓形成是血管成形术后的严重并发症，因此在随访中能够量化再狭窄的进展非常重要。如果可以通过放置在患者胸部外部的简单听诊仪器来量化闭塞，则可以监测再狭窄，并且可以在致命血栓形成发生之前安排干预。这种用于支架患者监测的替代仪器还提供了显著的成本降低，因为它代替了执行血管造影或超声以确定动脉中是否存在闭塞。在这个GOALI项目中，研究团队将开发一种可穿戴听诊系统，以改善冠状动脉闭塞的检测和定位，使用基于记录和分析与闭塞冠状动脉中湍流血流相关的孤立舒张心音的方法。该可穿戴系统包括一个智能、小尺寸、低噪声和高动态范围的MEMS麦克风阵列，用于记录，以及一个手持系统，用于预处理和无线传输与冠状动脉闭塞相关的湍流心音。由于它们精确匹配的响应，所提出的麦克风阵列系统将实现声源的高精度定位和方向性。该系统还采用先进的处理和可视化技术，使用个人数字助理（PDA）系统进行声音分析。考虑到与冠状动脉内支架植入相关的风险，本研究的目的是研究高度专业化的听诊系统在支架植入前后检测冠状动脉狭窄严重程度和位置的能力。另一个长期临床目标是通过收集入组研究超过两年的患者的随访数据，研究该系统的诊断能力，以评估裸金属或药物洗脱支架是否与再狭窄发生率较高相关。将与工业合作伙伴Renegesis，Biomedical Inc.合作进行MEMS麦克风阵列，微电子和无线系统开发的基础研究。该系统还可用于研究外周血管疾病，包括肾动脉和颈动脉闭塞以及下肢闭塞。它也可以用于心脏瓣膜病的检测。此外，该项目为工程师，医生，医学物理学家和行业之间的互动提供了一个跨学科的环境，并将进一步加强学术，行业和诊所之间的学术和研究互动。

CBET-0828912AkayCoronary artery disease (CAD) is one of the leading causes of death in the world with one third of all deaths attributed to this disease. It was estimated that 6 million patients have received drug eluting stents world wide which may pose the potential risk of sub acute thrombosis. Restenosis can occur up to one year or more after implantation of the stent device. A thrombosis that occurs this far after the stent has been inserted is fatal in 45% of cases. Because late stent thrombosis is such a serious complication after angioplasty it is important to be able to quantify the progression of restenosis in follow-up visits. If occlusion can be quantified by a simple auscultation instrument placed externally on the chest of the patient then restenosis can be monitored and an intervention can be scheduled before a fatal thrombosis occurs. This alternate instrumentation for stent patient monitoring also offers a significant cost reduction as it takes the place of performing an angiography or ultrasound to determine if there is an occlusion in the artery. In this GOALI Project, the research team will develop a wearable auscultation system to improve the detection and localization of coronary occlusions using an approach based on the recording and analysis of isolated diastolic heart sounds associated with turbulent blood flow in occluded coronary arteries. The wearable system consists of an intelligent, small-size, low noise and high dynamic range MEMS microphone array for the recording, and a handheld system for preprocessing and wireless transmission of turbulent heart sounds associated with coronary occlusions. Due to their precisely matched response, the proposed microphone-array system will enable high accuracy localization, and directionality of the acoustic source. The system also incorporates advanced processing and visualization techniques using a personal digital assistant (PDA) system for the analysis of sounds. Given the risks associated with the stent placement within the coronary arteries, the aim of this study is to investigate the ability of a highly specialized auscultation system to detect the severity and location of coronary artery stenoses before and after the stent placement. An additional long-term clinical goal is to investigate the diagnostic ability of the system to assess whether bare metal or drug eluting stents are related to higher incidence of restenosis by collecting follow up data from patients enrolled in the study for more than two years. Fundamental research on the development of MEMS microphone array, micro electronics and wireless system will be performed in collaboration with the industrial partner, Renegesis, Biomedical Inc.The proposed system can also be used for the investigation of peripheral vascular diseases including renal artery and carotid occlusions as well as lower extremity occlusions. It can also be used in detection of valvular heart disease. In addition, the project provides an interdisciplinary environment for interactions between engineers, physicians, medical physicists and industry and will further enhance the academic and research interactions between academic, industry and clinics.