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: 6742815
• 负责人: Judith K Gwathmey
• 金额: $ 22.78万
• 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/6742815
• 关键词: biological signal transduction; blood pressure; blood volume; disease /disorder model; electrocardiography; electrophysiology; heart disorder; heart function; heart ventricle; laboratory mouse; magnetic resonance imaging; measurement; technology /technique development; telemetry; transfection

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）： 心脏病是美国的首要死因。一百万美国人死于心脏病，即每 33 秒就有一人死于心脏病。小鼠的遗传改变已成为了解心血管研究中基本信号传导的有力工具。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性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。使用啮齿动物进行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。每年有超过 6900 万美元外包用于心血管药物的临床前测试。联邦监管指南要求在研究性新药应用 (1ND) 的临床前毒理学研究中使用一种啮齿类动物和一种非啮齿类动物。最近，FDA 宣布所有药物，无论是否寻求心血管适应症，都需要接受心血管筛查。由于这些原因，评估小型啮齿动物的心脏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方面实力雄厚的公司与一家设备开发和营销公司之间的合作，我们将开发、测试和销售一种新型遥测设备，用于在自由活动和有意识的情况下同时测量左心室压力、左心室容积和心电图啮齿动物。 在拟议的研究中，我们计划展示我们提出的设备的医学和工程可行性，包括关键设备组件的开发和初始数据收集。更全面的开发和验证工作将在后续的第二阶段应用中进行。