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

7.项目摘要/摘要 这个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特征。左心室收缩和舒张期 心肌损害是最常见的表现，收缩功能是用左心监测的。 测量左心室射血分数和左心室充盈监测舒张期功能 压力。这两项测量是在阅读和分析超声心动图后得到的 考试。据报道，收缩功能障碍的发生率约为2%，舒张期功能障碍的发生率为 在没有已知心脏病的糖尿病患者中，约有30%。即使发展到今天 心血管疾病是1型糖尿病最常见的并发症，超声心动图不是常规检查 在1型糖尿病患者中进行。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，以便在早期和潜在地发现心功能不全 可逆期，发病前出现临床体征和症状。在任何患者身上使用设备的能力 任何医疗保健专业人员的护理环境，如果没有超声心动图的特殊要求，将是 重要的价值。为了实现早期识别心脏功能障碍的目标，AventuSoft正在开发一种 使用心音测量收缩功能的新型便携式医疗设备(HemoTag)。 通过这个SBIR项目，我们将开发包括快速和自动化测量的技术 舒张期功能，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性研究，通过使 使用HemoTag自动表征心肌功能。其大小和成本仅为 目前的产品，HemoTag可以实现医疗保健可靠、准确和易于使用的应用程序 专业人员，用于测量心肌收缩和舒张期性能。它克服了 现有超声心动图设备的成本、尺寸和技术人员要求的限制。第二阶段 活动将集中在更大的多中心临床研究，加强早期发现的技术， FDA 510(K)上市前通知所需的验证和验证测试要求 将该系统用于商业用途。这一开创性工作的好处是开发了一种低成本- 成本和便携设备，将具有早期检测、诊断和量化的巨大潜力 糖尿病中的心血管疾病和心肌病并发症。HemoTag可以帮助解决 通过先进的成像设备，患者安全方面的重大问题，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员。

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.