A mobile health framework for left ventricular end diastolic pressure diagnostics and monitoring.

用于左心室舒张末压诊断和监测的移动健康框架。

• 批准号: 10601929
• 负责人: Kaustubh Kale
• 金额: $ 40万
• 依托单位: AVENTUSOFT, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10601929
• 关键词: Accounting; Acute; Address; Affect; African American population; Age; Algorithms; Android; Area; Biological; Biosensor; Blood Pressure; Cardiac; Cardiac Catheterization Procedures; Cardiac health; Cardiopulmonary; Cardiovascular Diseases; Caring; Catheters; Cause of Death; Cellular Phone; Cessation of life; Chest wall structure; Chronic; Clinic; Clinical; Collaborations; Communities; Data; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; Diastolic blood pressure; Disease Management; Early Diagnosis; Echocardiography; Engineering; Evaluation; Female; Florida; Goals; Health; Health Fairs; Health Personnel; Health Professional; Health Services Accessibility; Health Technology; Heart; Heart Auscultation; Heart Diseases; Heart failure; Height; Home; Improve Access; Institution; Institutional Review Boards; Joints; Left; Measurement; Measures; Medical; Medical center; Methods; Minor; Monitor; Morphologic artifacts; Motion; Noise; Not Hispanic or Latino; Pathologic; Pathway interactions; Patient Representative; Patients; Performance; Phase; Physicians; Physiologic Monitoring; Pilot Projects; Predictive Value; Prevention; Preventive; Primary Care; Public Health; Reduce health disparities; Resource-limited setting; Running; Science; Signal Transduction; Site; Small Business Innovation Research Grant; Specificity; System; Technology; Telemedicine; Testing; Training; Triage; Underserved Population; Validation; Variant; Ventricular; Visit; Weight; Woman; Work; checkup examination; clinical diagnostics; clinical practice; commercialization; cost; cost effective; detection method; evidence base; handheld mobile device; health care quality; health disparity populations; heart disease risk; improved; innovation; insight; mHealth; male; meetings; men; minority disparity; novel; portability; pressure; provider communication; recruit; screening; sensor; skills; smartphone application; telehealth; time interval

PROJECT SUMMARY/ABSTRACT This SBIR Fast-Track project will develop a novel mobile health framework for left ventricular end diastolic pressure diagnostics and monitoring, using an innovative, non-invasive cardiac biosensor. Heart disease is the leading cause of death for men and women accounting for more than one-third (33.6%) of all U.S. deaths. The total costs associated with cardiovascular disease in the U.S. were estimated to be $363 billion, making it the costliest health problem facing the nation. In addition, it occurs disproportionately among minority and health disparity populations. For example, heart failure related deaths are 30% higher among African-Americans than among non-Hispanic whites. Left ventricular end diastolic pressure (LVEDP) is a reflection of ventricular compliance and intravascular volume and pressure; it relates both acutely and chronically to clinical conditions that affect ventricular performance. LVEDP is elevated in the setting of heart failure (HF), and its measurement is used in the management of HF. Overall cardiac health can be significantly improved by proper triage at the primary care level by determination of the LVEDP without requiring a 2-D echo-cardiogram or left heart catherization. It will provide health care professionals with technology to guide diagnostic and facilitate easy home-based management by patients. Using everyday smartphones makes it even more accessible and readily available without adding high costs. As the technology being developed does not require skilled operators or specially trained physicians, it will allow healthcare providers to assess LVEDP within their normal medical training. Through the course of this project we will validate this revolutionary mobile health framework that enables measurement of LVEDP using everyday smartphones. The scope of the science proposed in this project is to complete development of the diagnostic framework using our specially engineered sensor system combined with the novel algorithm technology to be accessed via a smartphone for a portable and cost- effective solution. Resource-poor communities across the globe lack access to quality healthcare arising from shortages in medical expertise and poor availability of expensive medical diagnostic devices. In recent years, mobile phones have become increasingly advanced and ubiquitous. The mobile framework developed through this project is a tremendous opportunity to provide low-cost diagnostics to under-served populations. The benefit of this pioneering work is the development of an easy-to-use solution that can measure ventricular compliance, and thus enable improved screening during routine annual checkups, doctor visits, at community medical screenings, classes, and health fairs leading to healthier communities. It will make measuring LVEDP as routine as measuring blood pressure. In Phase II, we will continue validation of the device through user- trials and seek FDA 510(k) clearance for commercialization. Followed by commercialization in the Florida and nationwide, based on the partnerships and joint collaborations established to help create a commercially successful product.

项目总结/摘要 该SBIR快速通道项目将开发一种新的左心室舒张末期移动的健康框架， 压力诊断和监测，使用创新的，非侵入性的心脏生物传感器。心脏病是 这是男性和女性的主要死因，占美国所有死亡人数的三分之一以上（33.6%）。的 在美国，与心血管疾病相关的总费用估计为3630亿美元，使其成为 国家面临的最昂贵的健康问题。此外，少数群体和健康群体中发生这种情况的比例不成比例。 人口差距。例如，非裔美国人与心力衰竭相关的死亡率比非裔美国人高30%。 在非西班牙裔白人中。左室舒张末压（LVEDP）是心室收缩功能的反映， 顺应性和血管内容量和压力;它与临床状况急性和慢性相关 影响心室性能的因素LVEDP在心力衰竭（HF）的情况下升高，并且其测量 用于HF的管理。通过适当的分流，可以显著改善整体心脏健康。 通过测定LVEDP而无需2-D超声心动图或左心的初级护理水平 插管它将为医疗保健专业人员提供技术，以指导诊断， 病人居家管理。使用日常智能手机使其更容易获得， 容易获得而不增加高成本。由于正在开发的技术不需要熟练的 操作员或经过专门培训的医生，它将允许医疗保健提供者在其正常范围内评估LVEDP， 医学训练通过这个项目的过程中，我们将验证这一革命性的移动的健康框架 可以使用日常智能手机测量LVEDP。本书中提出的科学范围 项目是完成诊断框架的开发，使用我们专门设计的传感器系统 结合通过智能手机访问的新算法技术， 有效的解决方案。地球仪上资源贫乏的社区无法获得高质量的医疗保健， 缺乏医疗专门知识和昂贵的医疗诊断设备。近年来， 移动的电话已经变得越来越先进和普遍。通过以下方式开发的移动的框架 这一项目是向服务不足的人口提供低成本诊断的巨大机会。的 这项开创性工作的好处是开发了一种易于使用的解决方案，可以测量心室 合规性，从而能够在例行年度检查、医生访问、社区 医疗检查、课程和健康博览会，从而建立更健康的社区。这将使测量LVEDP 就像测量血压一样。在第二阶段，我们将继续通过用户验证设备- 试验并寻求FDA 510（k）商业化许可。其次是商业化在佛罗里达和 在全国范围内，基于建立的伙伴关系和联合合作，以帮助建立一个商业 成功的产品。