Population Screening with Respect to Cardiac Ischemia

描述（由申请人提供）：心肌缺血（CI）的早期检测对于冠状动脉疾病（CAD）的诊断和治疗非常重要。CI通常首先观察到运动期间ECG ST段的变化。然而，大量文献表明ST段变化相对不敏感，仅是一种中度特异性的CAD预测因子。因此，大多数临床医生建议患者进行更昂贵和劳动密集型的放射性同位素成像。在无症状人群中检测CI的更简单，廉价和可靠的技术将通过大规模心脏筛查和更好地管理CAD患者打开CAD早期诊断的大门。Mediwave星星技术（MSTI）的试点研究表明，心率变异性（HRV）在专有的准静态往返运动方案中遵循滞后模式。我们建议使用这种现象作为一个简单的廉价的测试使用市售的数字心率监测器的基础。MSTI与克利夫兰临床基金会合作，刚刚完成了一项涉及260名患者的盲法临床研究的数据收集，最初旨在将我们的QT-RR滞后技术与放射性同位素成像进行比较。我们建议重新处理这些数据，以评估我们的HRV滞后方法的特异性和敏感性。这将开辟一个新的途径，一个简单和廉价的非侵入性工具，早期诊断CI的大规模筛查无症状人群。

DESCRIPTION (provided by applicant): Early detection of cardiac ischemia (CI) is important for diagnosis and treatment of coronary artery disease (CAD). CI is usually first observed as changes in ECG's ST segment during exercise. However, there is an extensive body of literature showing that the ST segment change is relatively insensitive and only a moderately specific CAD predictor. Hence, most clinicians refer patients for more expensive and labor intensive radioisotope imaging. A simpler, inexpensive and reliable technology for detecting CI in an asymptomatic population would open the door to early diagnostics of CAD through mass cardiac screening and better management of CAD patients. Mediwave Star Technology (MSTI) pilot studies revealed that heart rate variability (HRV) follows a hysteresis pattern during a proprietary quasi-stationary there-and-back exercise protocol. We propose to use this phenomenon as a basis for a simple inexpensive test using commercially available digital heart rate monitors. MSTI in collaboration with Cleveland Clinic Foundation has just completed data collection in a blind clinical study involving 260 patients and initially aimed at comparison of our QT-RR hysteresis technology with radioisotope imaging. We propose to reprocess these data to assess specificity and sensitivity of our HRV hysteresis method. This will open up a new avenue for a simple and inexpensive non-invasive tool for early diagnostics of CI in mass screening of asymptomatic population.