Detection of cardiac ischemia using magnetocardiography

描述(申请人提供)：MagneSensors的项目旨在开发一种新型的磁心动图(MCG)仪器，该仪器使用磁性传感器快速、非侵入性地检测心肌缺血。提出的心电图仪利用超灵敏超导量子干涉器件(SQUID)来检测心脏电活动产生的磁场。该项目将使用创新的高温(高温)SQUID技术来生产广泛临床应用所需的便携式、低成本仪器。胸痛是美国急诊室入院的第二大原因，排除急性心肌梗死(AMI)的相关成本超过30亿美元。现有的技术，如生物标记物血液检测和心电图仪，是不充分的，无法防止错过的急性心肌梗死的不良后果和不必要的住院的巨大成本。据估计，仅在急诊科，美国心磁图仪器的市场规模就接近10亿美元。最近发表的研究为心磁图在心肌缺血检测中的应用奠定了基础。在MCG制作的二维磁场图上，缺血组织的存在表现为异常。新的算法表明，心电地形图可以达到很高的阴性预测值，这是排除急性心肌梗死的关键。第一阶段的工作重点是证明高T_c SQUID传感器可以在“无屏蔽”的环境中工作，具有足够的灵敏度来检测必要的心脏信号。由于数据分析可以使用平均的MCG波形，因此不需要极高的SQUID灵敏度。高T_c传感器采集的心电数据的非屏蔽测量将与常规低T_c系统的M_cG数据进行比较，以证明高T_c传感器的信噪比足以用于检测。第一阶段旨在开发概念验证能力，以证明第二阶段计划的合理性，该计划旨在制造临床使用的便携式心磁图仪器，并在急诊科检查患者。

DESCRIPTION (provided by applicant): MagneSensors' program is aimed at developing a novel magnetocardiography (MCG) instrument that uses magnetic sensors for the rapid, non-invasive detection of cardiac ischemia. The proposed MCG instrument takes advantage of ultra-sensitive superconducting quantum interference devices (SQUIDs) to detect the magnetic fields generated by electrical activity in the heart. The program will use innovative high temperature (high-Tc) SQUID technology to produce the portable, lower cost instruments that are necessary for widespread clinical application. Chest pain is the second leading cause of admission in emergency rooms in the U.S and the costs associated with ruling out acute myocardial infarction (AMI) exceeds $3 billion. Existing techniques such as biomarker blood tests and electrocardiography (ECG) are inadequate and unable to prevent adverse outcomes of missed AMI and the huge costs of unnecessary hospitalization. The U.S. market for MCG instrumentation is estimated at near $1 billion in the emergency department alone. Recent published studies have laid the groundwork for the application of MCG to the detection of cardiac ischemia. The presence of ischemic tissue shows up as abnormalities on two-dimensional magnetic field maps produced by MCG. New algorithms have shown that MCG can achieve a high negative predictive value, which is essential for ruling out AMI. The Phase I effort focuses on demonstrating that high-Tc SQUID sensors can be operated in an "unshielded" environment with sufficient sensitivity to detect the necessary cardiac signals. Since the data analysis can use averaged MCG waveforms, the ultimate in SQUID sensitivity is not required. Unshielded measurements of MCG data taken with high-Tc sensors will be compared with MCG data from conventional low-Tc systems to demonstrate that the signal-to-noise of high-Tc sensors is sufficient for detection. Phase I is aimed developing a proof-of-concept capability to justify a Phase II program to build a portable MCG instrument for clinical use and to examine patients in the emergency department.