Acute Ischemia Monitor Utilizing Subcutaneous Electrodes

利用皮下电极监测急性缺血

• 批准号: 8252956
• 负责人: Bruce Hopenfeld
• 金额: $ 77.97万
• 依托单位: ANGEL MEDICAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8252956
• 关键词: Achievement; Acute; Acute myocardial infarction; Adoption; Algorithms; American; Balloon Angioplasty; Body Surface; Cardiac; Cardiology; Cause of Death; Cessation of life; Clinic; Clinical; Clinical Trials; Complex; Complication; Congestive Heart Failure; Control Groups; Coronary artery; Coronary heart disease; Data; Data Set; Databases; Detection; Development; Devices; Early Diagnosis; Early treatment; Economic Inflation; Electrodes; Environment; Evaluation; Event; Fluoroscopy; General Population; Goals; Healthcare; Healthcare Systems; Heart; Hospitals; Hour; Implant; In Situ; Incidence; Individual; Infection; Ischemia; Lead; Location; Medical; Methods; Monitor; Morbidity - disease rate; Myocardial Infarction; Operative Surgical Procedures; Outcome; Pacemakers; Patients; Phase; Physicians; Population; Process; Quality of life; Recruitment Activity; Research; Resources; Risk; Running; Safety; Signal Transduction; Simulate; Source; Surface; Survivors; Symptoms; System; Target Populations; Technology; Testing; Time; Tissues; United States; United States Food and Drug Administration; Work; cost; high risk; implantable device; improved; memory process; mortality; novel; patient population; programs; psychologic; research and development; sensor; subcutaneous; vector

DESCRIPTION (provided by applicant): This project consists of the research and development of a unique implantable ischemia monitor that uses subcutaneous sensors in the patient's torso to detect the onset of acute myocardial infarction (AMI). Upon detecting a heart attack, the monitor generates an alarm, which enables the patient to promptly seek medical treatment. In the United States, the median symptom-to-hospital time is 2.4 hours. Lengthy delays between symptom onset and a patient's arrival at a hospital cause both substantial heart tissue damage and many deaths. Approximately 50% of heart attack patients have either atypical or no symptoms at all, causing significant delays in treatment. Each 30 minute reduction of treatment delay provides a 7.5% decrease in mortality and 8.7% decrease in the incidence of congestive heart failure. Prompt treatment of AMIs enabled by real-time ischemia monitoring and alerting will save lives and decrease morbidity. In 2010, approximately 1.4 million people in the United States will have heart attacks, and approximately 400,000 of these victims will die. A chronically implanted monitor that provides early warnings of heart attacks could greatly reduce time to treatment, which in turn will dramatically decrease heart-attack related deaths and improve the quality of life of heart attack survivors. This monitor will be an important health care advance since coronary heart disease is the top cause of death in the U.S. and one of the leading costs to the healthcare system. This Phase II research builds upon our successful Phase I work, which entailed the development and evaluation of an ischemia detection algorithm using a small patient population. This Phase II project will result in the creation of a monitor that is ready for a clinical safety trial. This goal will be realized by achieving the following aims: Aim 1. Demonstrate the efficacy of an algorithm that will run within an implantable device that utilizes two subcutaneous vectors. In this aim, we will evaluate and refine the Phase I algorithm by testing it on two datasets. The first dataset will include Holter recordings from a control group of 36 high-risk individuals who will be monitored for approximately 2 weeks (no ischemia detections should occur in this group). The second dataset will include 24-hour, 12- lead recordings from hundreds of cases of confirmed AMIs. Aim 2 Demonstrate the functionality of the entire monitoring system, including the implantable device, the physician's programmer that remotely programs the implantable device in situ, and the subcutaneous lead. To further the achievement of this aim, the algorithm will be implemented within a new implantable hardware platform. Successful completion of this aim will be shown when the entire system passes all tests required to obtain United States Food and Drug Administration approval for a clinical safety trial. PUBLIC HEALTH RELEVANCE: Heart attacks are the leading cause of death in the United States. Early detection of heart attacks by an implantable monitor will help to save lives and improve heath of survivors.

描述（由申请人提供）：该项目由独特的植入缺血监测仪的研究和开发组成，该植入性缺血监测仪使用患者躯干中的皮下传感器来检测急性心肌梗塞（AMI）的发作。检测到心脏病发作后，监视器会产生警报，这使患者能够及时寻求医疗治疗。在美国，中位症状到院时间为2.4小时。症状发作和患者到达医院之间的漫长延误既会导致心脏组织损害又大量死亡。大约50％的心脏病发作患者根本没有症状或根本没有症状，从而导致严重的治疗延迟。每30分钟的治疗延迟减少，死亡率下降7.5％，充血性心力衰竭发病率降低了8.7％。通过实时缺血监测和警报启用AMI的及时处理将节省生命并减少发病率。 2010年，美国大约有140万人心脏病发作，其中约40万人将死亡。一家长期植入的监测仪，发出心脏病发作的早期警告可能会大大减少治疗时间，进而大大减少心脏攻击相关的死亡并改善心脏病发作幸存者的生活质量。由于冠心病是美国死亡的主要原因，也是医疗保健系统的主要成本之一，因此该监测器将是重要的医疗保健。这项第二阶段的研究基于我们成功的I期工作，该工作需要使用少数患者人群对缺血检测算法进行开发和评估。该第二阶段项目将导致创建准备进行临床安全试验的监视器。通过实现以下目标来实现此目标：目标1。证明将在利用两个皮下向量的可植入设备中运行的算法的功效。在此目标中，我们将通过在两个数据集上测试I阶段算法来评估和完善I阶段算法。第一个数据集将包括来自36个高风险个体的对照组的Holter记录，这些录音将大约2周监测（该组中不应发生缺血检测）。第二个数据集将包括数百例已确认AMI的24小时，12个铅记录。 AIM 2演示了整个监视系统的功能，包括可植入设备，医师的程序员，该程序员远程编程原位植入设备以及皮下铅。为了进一步实现此目标，该算法将在新的可植入硬件平台中实现。当整个系统通过获得美国食品和药物管理局批准进行临床安全试验所需的所有测试时，将成功完成此目标。 公共卫生相关性：心脏病发作是美国死亡的主要原因。植入式监测器对心脏病发作的尽早发现将有助于挽救生命并改善幸存者的健康。