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

7.项目总结/摘要 SBIR第一阶段项目将开发一种创新的医疗设备，用于快速自动化 糖尿病患者心肌功能的表征。左室收缩和舒张 心肌损害是最常见的表现，左室收缩功能监测 测量心室射血分数，并通过左心室充盈监测舒张功能 压力在阅读和分析超声心动图后，可获得这两个测量值。 考试据报道，收缩功能障碍的发生率约为2%，舒张功能障碍的发生率约为2%。 大约30%的糖尿病患者没有已知的心脏病。尽管发展 心血管疾病是1型糖尿病最常见的并发症， 1型糖尿病的治疗方法因此，心脏病专家和患者护理提供者需要 合作确定新的非侵入性技术，以早期检测心功能障碍， 可逆阶段，在临床体征和症状发作之前。在任何患者中使用器械的能力 任何医疗保健专业人员的护理设置，如果没有超声心动图的特殊要求， 重要的价值。为了实现早期识别心功能不全的目标，AventuSoft正在开发一种 新型便携式医疗器械（HemoTag），使用心音测量心脏收缩功能。 通过这个SBIR项目，我们将开发技术，包括快速和自动测量 舒张功能而不需要超声心动图。在第一阶段SBIR期间，AventuSoft团队将 完成对糖尿病患者的验证研究，以证明通过使 使用HemoTag自动表征心肌性能。尺寸和成本仅为 目前的产品，HemoTag可以实现可靠，准确和易于使用的应用，由医疗保健 专业人员，用于测量心肌收缩和舒张性能。它克服了 现有超声心动图装置的成本、尺寸和熟练人员要求的限制。二期 活动将集中在更大的多中心临床研究，提高早期检测技术， FDA 510（k）上市前通知所需的验证和确认试验要求，以及 将该系统产品化用于商业用途。这项开创性工作的好处是开发了一种低- 成本和便携式设备，将有很大的潜力，为早期检测，诊断和量化， 糖尿病并发心血管疾病和心肌病。HemoTag可以帮助解决 尽管成像设备的进步，但患者安全的重大问题使其更容易获得 并且容易获得，因为该技术不需要熟练的受过专门训练的操作者。

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.