Assessment of a Telemetered PV-ECG System: Murine Models

超出提供的空间。心脏病是美国人的主要死因。100万美国人死于心脏病，或者说大约每33秒就有一人死于心脏病。在心血管研究中，小鼠的遗传改变已成为了解基本信号的有力工具。由于基因操作的简便性，对小型啮齿动物的研究有所增加。通过基因转移或突变改变心肌功能有望成为预防或纠正获得性和遗传性心脏病的一种机制。利用啮齿动物进行临床前药物测试需要可靠的生理手段来量化体内的心脏功能。每年有超过6900万美元被外包用于心血管药物的临床前测试。联邦监管指南要求在新药研究的临床前毒理学研究中使用一种啮齿动物和一种非啮齿动物(1ND)。最近，FDA宣布，所有药物，无论是否寻求心血管适应症，都将被要求接受心血管筛查。由于这些原因，评估小型啮齿动物的心功能和电记录变得非常重要。通过一家在动物测试和心血管表型鉴定方面实力雄厚的公司与一家设备开发和营销公司建立合作伙伴关系，我们将开发、测试和营销一种新型遥测设备，用于在自由活动和清醒的啮齿动物身上同时测量左室压、左室容量和心电图。在拟议的研究中，我们计划证明我们提议的设备在医学和工程上的可行性，包括关键设备部件的开发和初始数据收集。更全面的开发和验证工作将在随后的第二阶段应用中进行。表演网站========================================Section End===========================================

EXCEED THE SPACE PROVIDED. Heart disease is the leading cause of death in the United States. One million Americans die from heart disease or about one person every 33 seconds. Genetic alterations of mice have become a powerful tool in understanding basic signaling in cardiovascular research. The study of small rodents has increased as a result of the ease of genetic manipulation. Modification of cardiac muscle performance through gene transfer or mutation holds promise as one mechanism to prevent or correct acquired and inherited cardiac diseases. The use of rodents for pre-clinical testing of drugs requires reliable and physiological means for quantifying cardiac function in vivo. Over $69 million dollars a year are outsourced for pre-clinical testing of cardiovascular drugs. Federal regulatory guidelines require the use of one rodent species and one non-rodent species in pre-clinical toxicology studies for Investigational New Drug applications (1ND). Recently the FDA announced that all agents whether or not seeking cardiovascular indications, will be required to undergo cardiovascular screening. For these reasons, it has become very important to evaluate cardiac function and electrical recordings in small rodents. Through a partnership between a company strong in animal testing and cardiovascular phenotyping with a device development and marketing company, we will develop, test and market a novel telemetered device for measuring left ventricle pressure, left ventricle volume, and electrocardiograms simultaneously in freely moving and conscious rodents. In the proposed study we plan to demonstrate both medical and engineering feasibility of our proposed device, including the development of key device components and initial data collection. More comprehensive development and validation work will be carried out in a subsequent Phase 2 application. PERFORMANCE SITE ========================================Section End===========================================