Innovation for the earlydetection, diagnosis, and quantification of diabetic cardiomyopathy.

糖尿病心肌病早期检测、诊断和量化的创新。

基本信息

批准号：
9407278
负责人：
Kaustubh Kale
金额：
$ 22.5万
依托单位：
AVENTUSOFT, LLC
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-06-06 至 2017-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9407278
关键词：
Address Affect Age Algorithms Area Auditory Biological Cardiac Cardiology Cardiomyopathies Cardiovascular Diseases Cardiovascular system Cause of Death Cessation of life Chairperson Classification Clinic Clinical Cloud Computing Complication Computers Detection Development Devices Diabetes Mellitus Diagnosis Diastolic blood pressure Disease Doctor of Medicine EKG QRS Complex Early Diagnosis Early identification Echocardiography Endocrine Endocrinologist Engineering Enhancement Technology Equipment Etiology Evaluation Event Florida Functional disorder General Population Goals Health Insurance Portability and Accountability Act Health Professional Health Services Research Heart Heart Atrium Heart Diseases Heart Sounds Hospitals Human Resources Image Impairment Incidence Institutional Review Boards Insulin-Dependent Diabetes Mellitus Left Left Ventricular Dysfunction Left Ventricular Ejection Fraction Length Master of Public Health Measurement Measures Medical Device Medical center Metabolic Methods Mitral Valve Monitor Multi-Institutional Clinical Trial Myocardial Myocardial dysfunction Myocardial tissue Notification Output Patient Care Patient risk Patients Performance Phase Prevention Provider Public Health Pulmonary valve structure Reading Reporting Research Institute Scientist Signal Transduction Signs and Symptoms Site Small Business Innovation Research Grant Specialist System Systemic disease Techniques Technology Testing Time Tissues Training Tricuspid valve structure United States Dept. of Health and Human Services Universities University Hospitals Ventricular Work aortic valve base cardiovascular disorder risk clinical practice cost diabetes risk diabetic cardiomyopathy evidence base improved innovation insight minority health novel outcome forecast patient safety portability pre-clinical pressure prevent professor prognostic signal processing time interval validation studies verification and validation web interface

项目摘要

7. PROJECT SUMMARY/ABSTRACT This SBIR Phase I project will develop an innovative medical device useful for rapid automated characterization of myocardial performance in diabetes patients. Left ventricular systolic and diastolic myocardial impairment is the most common manifestation; and the systolic function is monitored with left ventricular ejection fraction measurement and the diastolic function is monitored with left ventricular filling pressure. These two measurements are available after reading and analyzing the echocardiographic examinations. The reported incidence of systolic dysfunction is approximately 2% and diastolic dysfunction is approximately 30% in diabetes patients without known heart disease. Even though the development of cardiovascular disease is the most common complication of type 1 diabetes, echocardiography is not routinely performed in patients with type 1 diabetes. Thus, the cardiologist and patients care provider need to collaborate to identify new non-invasive techniques to detect cardiac dysfunction at an early and potentially reversible stage, before the onset of the clinical signs and symptoms. The ability to use a device in any patient care setting by any healthcare professional, without the special requirement of an echocardiogram, would be of significant value. Towards this goal of early identification of cardiac dysfunction, AventuSoft is developing a novel portable medical device (HemoTag) to provide measurement of systolic function using heart sounds. Through this SBIR project, we will develop technology to include the rapid and automated measurement of diastolic function without requiring an echocardiogram. During this Phase I SBIR, the AventuSoft team will complete validation studies with diabetes patients to demonstrate a major clinical advancement by enabling the automated characterization of myocardial performance using HemoTag. At a fraction of the size and cost of current products, HemoTag can enable reliable, accurate and easy-to-use application by healthcare professionals, for the measurement of myocardial systolic and diastolic performance. It overcomes the limitations of cost, size and skilled personnel requirements of existing echocardiography devices. Phase II activities will focus on larger multi-center clinical studies, enhancing the technology for early detection, verification and validation testing requirements necessary for the FDA 510(k) premarket notification, and on productizing the system for commercial use. The benefit of this pioneering work is the development of a low- cost and portable device that will have great potential for early detection, diagnosis, and quantification of cardiovascular disease and cardiomyopathy complications in diabetes. HemoTag can help address the significant problems of patient safety though advancements in imaging equipment, make it more accessible and readily available as the technology does not require skilled specially trained operators.

7。项目摘要/摘要这个SBIR阶段项目将开发一种创新的医疗设备，可用于快速自动化糖尿病患者心肌表现的表征。左心室收缩和舒张压心肌障碍是最常见的表现。并用左侧监视收缩功能心室射血分数测量和舒张功能通过左心室填充进行监测压力。在阅读和分析超声心动图后，可以使用这两个测量值考试。报告的收缩功能障碍的发生率约为2％，舒张功能障碍为没有已知心脏病的糖尿病患者中约有30％。即使发展心血管疾病是1型糖尿病的最常见并发症，超声心动图不是常规的在1型糖尿病患者中进行。因此，心脏病专家和患者护理人员需要协作以确定新的非侵入性技术，以早期且可能可逆阶段，在临床体征和症状发作之前。在任何患者中使用设备的能力任何医疗保健专业人员的护理设置，没有超声心动图的特殊要求，将是显着价值。为了提前确定心脏功能障碍的目标，Aventusoft正在开发一个新颖的便携式医疗设备（Shemotag）使用心脏声音提供收缩功能的测量。通过这个SBIR项目，我们将开发技术，包括快速和自动化的测量舒张功能无需超声心动图。在这个阶段I SBIR中，Aventusoft团队将与糖尿病患者进行完整的验证研究，以证明可以通过实现使用Shemotag对心肌性能的自动表征。大小和成本的一小部分当前产品，Shemotag可以通过医疗保健实现可靠，准确且易于使用的应用专业人士，用于测量心肌收缩和舒张性表现。它克服了现有超声心动图设备的成本，规模和熟练人员要求的限制。第二阶段活动将集中于更大的多中心临床研究，增强了早期检测的技术， FDA 510（k）上市通知所需的验证和验证测试要求以及生产用于商业用途的系统。这项开创性工作的好处是开发低 - 成本和便携式设备将有很大的潜力进行早期检测，诊断和定量糖尿病的心血管疾病和心肌病并发症。 Shemotag可以帮助解决尽管成像设备方面的进步，患者安全的重大问题，使其更容易访问并且由于技术不需要熟练训练的操作员而容易获得。