Assessment of a Telemetered PV-ECG System: Murine Models

遥测 PV-ECG 系统的评估：小鼠模型

• 批准号: 7002038
• 负责人: Judith K Gwathmey
• 金额: $ 6.15万
• 依托单位: GWATHMEY, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-10 至 2005-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7002038
• 关键词: Assessment; Telemetered; PV; ECG; System; Assessment; Telemetered; PV; ECG; System

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===========================================

超过提供的空间。心脏病是美国死亡的主要原因。一百万美国人死于心脏病或大约一个人每33秒死亡。小鼠的遗传改变已成为理解心血管研究中基本信号传导的强大工具。小啮齿动物的研究增加了遗传操作的易用性。通过基因转移或突变对心肌性能的改变具有预防或纠正获得和遗传性心脏病的一种机制。使用啮齿动物的药物临床前测试需要可靠的生理手段来量化体内心脏功能。每年超过6,900万美元用于对心血管药物进行临床前测试。联邦监管指南要求在临床前毒理学研究中使用一种啮齿动物物种和一种非变形物种用于研究新药应用（1ND）。最近，FDA宣布，无论是否寻求心血管迹象，都需要进行心血管筛查。由于这些原因，评估小啮齿动物中的心脏功能和电记录变得非常重要。通过与设备开发和营销公司在动物测试方面的强大公司与心血管表型之间的合作关系，我们将开发，测试和销售一种新型的遥测设备，用于测量左心室压力，左心室体积，心电图以及在自由移动和有意识的啮齿动物中同时使用心电图。在拟议的研究中，我们计划证明我们提出的设备的医学和工程可行性，包括开发关键设备组件和初始数据收集。更全面的开发和验证工作将在随后的2阶段应用中进行。表演站点=============================================================================================