IMPLANTABLE MYOCARDIAL ISCHEMIA DETECTION TECHNOLOGY

在美国，冠状动脉疾病是主要的死亡原因。在所有患有急性心肌梗死的患者中，有四分之一没有寻求治疗，只是在常规的心电图上了解到他们的病情及其相关的发病率。在确实寻求治疗的患者中，最重要的因素是从症状出现到治疗的时间。将这一因素减少到70分钟以下与死亡率从8.7%下降到1.2%相关。这种治疗的有效性通常会因为延迟就医或完全无法识别缺血事件而受到阻碍。因此，我们建议开展研究，最终开发用于起搏器和除颤器的可植入心肌缺血检测技术(IMIDT)。这项技术将提供缺血负荷的长期定量测量(静默和心绞痛)和急性缺血事件的识别。目前的目标(第一阶段)是获得概念证据，证明心肌缺血可以通过一种特殊的多极腔内导联系统准确地检测出来。我们打算在急性心肌缺血的动物模型中测试铅。我们将使用一种新的基于小波分析算法的时频窗滤波来分析电信号，并使用传统的缺血检测方法。结果将在组织学上得到验证。在第二阶段，我们将重点放在慢性猪模型和心导管实验室的患者研究上。在急性和慢性研究的基础上，我们希望与现有的起搏器公司建立合作，开发IMIDT并将其商业化，用于早期检测急性缺血事件和慢性监测缺血性心脏病的发生和发展。拟议的商业应用：我们的长期愿景是，IMIDT将被纳入用于检测和治疗心肌缺血的可植入设备中。现在有大量的患者安装了植入式起搏器，还有越来越多的植入型心脏复律和除颤器。IMIDT与植入性装置的不同适应症之间有很大的共病。因此，植入式起搏器或心律转复/除颤器有很好的市场，它还可以监测心脏的缺血状况。IMIDT很可能会被授权给一家老牌的起搏器/除颤器公司，后者将把它‘搭载’到这样的设备上。

Coronary artery disease is the leading cause of death in the United States. One quarter of all patients who suffer an acute myocardial infarction do not seek therapy, only to learn of their condition and its associated morbidity on routine electrocardiogram. Of the patients who do seek therapy, the most important factor is the time to treatment from the onset of symptoms. Reducing this factor to less than 70 minutes is associated with a decrease in mortality from 8.7% to 1.2%. This effectiveness of therapy is often hampered by delay in seeking medical attention or a complete inability to recognize the ischemic event. Therefore, we propose research that will eventually lead to development of Implantable Myocardial Ischemia Detection Technology (IMIDT), for use in pacemakers and defibrillators. This technology will provide both long term quantitative measure of ischemic burden (silent and anginal) and identification of acute ischemic events. The immediate goal (Phase I) is to obtain proof of concept that myocardial ischemia can be accurately detected by a special multipolar intracavitarv lead based system. We intend to test the lead in an acute animal model of myocardial ischemia. We will analyze the electrical signals using a novel time-frequency window filter based on wavelet analysis algorithm as well as by conventional ischemia detection methods. The results will be validated histologically. In Phase II we will focus on a chronic porcine model and on patient studies in the cardiac catheterization laboratory. Armed with acute and chronic studies, we hope to establish a collaboration with an existing pacemaker company to develop and commercialize IMIDT for early detection of acute ischemic events and chronic monitoring of the onset and progression of ischemic heart disease. PROPOSED COMMERCIAL APPLICATIONS: It is our long term vision that IMIDT will be incorporated into implantable devices for detection and treatment of myocardial ischemia. There now exists a large population of patients with implantable pacemakers and increasingly also implantable cardioverters and defibrillators. There is a good deal of comorbidity between IMIDT and the varied indications for implantable devices. Therefore, there is an excellent market for an implantable pacemaker or cardioverter/defibrillator that also monitors the ischemic conditions of the heart. IMIDT will very likely be licenced to an established pacemaker/defibrillator company that will 'piggyback' it onto such devices.