Acute Ischemia Monitor Utilizing Subcutaneous Electrodes

利用皮下电极监测急性缺血

基本信息

批准号：
7669871
负责人：
Bruce Hopenfeld
金额：
$ 16.85万
依托单位：
ANGEL MEDICAL SYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-07-01 至 2011-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7669871
关键词：
Acute Algorithms Anterior Arteries Attention Balloon Angioplasty Balloon Occlusion Body Surface Potential Mapping Carbon Cardiac Cause of Death Cessation of life Clinical Trials Collection Coronary Coronary heart disease Data Data Set Detection Development Devices Discrimination Early Diagnosis Electrodes Environment Evaluation Event FDA approved Grant Health Heart Heart Rate Holter Electrocardiography Implant Ischemia Lead Left Life Literature Location Measurement Medical Memory Monitor Morbidity - disease rate Morphologic artifacts Motion Myocardial Infarction Noise Patients Phase Population Positioning Attribute Recruitment Activity Research Respiration Right coronary artery structure Series Signal Transduction Small Business Innovation Research Grant Solutions Source Survivors System Techniques Time Time Series Analysis United States Work base body position design high risk implantable device improved monitoring device product development prototype public health relevance subcutaneous

项目摘要

DESCRIPTION (provided by applicant): We will develop a chronically implanted heart monitor that detects acute ischemia by analyzing electrocardiographic (ECG) waveforms recorded by subcutaneous electrodes. The two specific aims of this Phase I research are: (1) to further develop our ischemia detection algorithm by refining heart-rate based adjustment of ECG feature thresholds and optimizing temporal denoising and discrimination of ECG data and extracted features; and (2) to evaluate our refined ischemia detection algorithm by comparing the extent of ECG feature changes (e.g. ST segment changes) during intervals of induced acute ischemia with changes that occur during normal daily life. The latter aim will be achieved by recruiting 36 patients and recording two datasets for each patient. The first dataset will consist of Holter recordings from three candidate bipolar leads for 1-day before patients undergo balloon angioplasty. The second dataset will consist of Holter recordings that will be obtained from these patients during balloon angioplasty. The results of the research will be a refined and validated ischemia detection algorithm and the selection of two leads from our three candidate leads. Phase II of the project will entail creating a prototype device based on this algorithm and the chosen leads. PUBLIC HEALTH RELEVANCE: Heart attacks are the leading cause of death in the United States. Early detection of heart attacks by an implantable heart monitor will help to save lives and improve the health of survivors.

描述（由申请人提供）：我们将开发一个长期植入的心脏监护膜，该心脏监护膜通过分析皮下电极记录的心电图（ECG）波形来检测急性缺血。该阶段研究的两个具体目的是：（1）通过完善基于心脏的心率的ECG特征阈值调整并优化了对ECG数据和提取的特征的时间deNo和歧视，以进一步开发我们的缺血检测算法；（2）通过比较在诱导的急性缺血间隔期间与ECG特征变化的程度（例如，ST段变化）与正常日常生活中发生的变化进行比较，评估了我们精致的缺血检测算法。后一个目标将通过招募36名患者并为每位患者记录两个数据集来实现。第一个数据集将包括来自三个候选双极导线的录音，为期1天，然后患者接受气球血管成形术。第二个数据集将包括在气球血管成形术期间从这些患者那里获得的录音。该研究的结果将是一种精致验证的缺血检测算法，并从我们的三个候选潜在客户中选择了两个潜在客户。该项目的第二阶段将需要基于此算法和所选潜在客户创建原型设备。公共卫生相关性：心脏病发作是美国死亡的主要原因。植入式心脏监护仪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。