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.

项目摘要/摘要 这个SBIR快速轨道项目将为左心室舒张期开发一个新型的移动健康框架 使用创新的非侵入性心脏生物传感器的压力诊断和监测。心脏病是 男女的主要死亡原因占美国所有死亡人数的三分之一以上（33.6％）。这 与美国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，它发生在少数族裔和健康中 差异人群。例如，非裔美国人的心力衰竭死亡比 在非西班牙裔白人中。左心室末端舒张压（LVEDP）是心室的反射 依从性，血管内体积和压力；它与临床条件敏锐地和长期有关 影响心室性能。 LVEDP在心力衰竭（HF）及其测量中升高 用于HF的管理。通过适当的分类可以显着改善心脏健康的总体健康 通过确定LVEDP的初级保健水平，而无需2D回声图或左心 catherization。它将为医疗保健专业人员提供技术，以指导诊断并促进轻松 患者的家庭管理。使用日常智能手机使其更容易访问，并且 随时可用而没有增加成本。由于所开发的技术不需要熟练 运营商或经过特殊培训的医生，它将允许医疗保健提供者在正常情况下评估LVEDP 医学培训。通过该项目的过程，我们将验证这个革命性的移动健康框架 这样可以使用日常智能手机来测量LVEDP。在此提出的科学范围 项目是使用我们专门设计的传感器系统来完成诊断框架的开发 结合新颖的算法技术，将通过智能手机访问可移植和成本 - 有效的解决方案。全球资源贫乏的社区缺乏获得优质医疗保健的机会 昂贵的医疗诊断设备的医疗专业知识短缺和可用性差。最近几年， 手机已经变得越来越先进和无处不在。移动框架通过 该项目是为服务不足人群提供低成本诊断的巨大机会。这 这项开创性工作的好处是开发易于使用的解决方案，可以测量心室 合规性，从而在常规的年度检查，医生探访期间可以改善筛查 医疗检查，课程和健康展览会导致更健康的社区。这将使测量LVEDP 与测量血压一样常规。在第二阶段，我们将继续通过用户验证设备 - 试用并寻求FDA 510（k）清算以进行商业化。其次在佛罗里达州进行商业化和 在全国范围内，基于建立的合作伙伴关系和联合合作，以帮助创建商业 成功的产品。