Sympathetic Nerve Activity Recorded From the Skin and Cardiac Arrhythmias

从皮肤记录的交感神经活动和心律失常

• 批准号: 8779946
• 负责人: Thomas H Everett
• 金额: $ 21.26万
• 依托单位: ARRHYTHMOTECH, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8779946
• 关键词: Acceleration; Arrhythmia; Atrial Fibrillation; Canis familiaris; Cardiac; Cardiology; Chest; Clinical Research; Collaborations; Consent; Data; Detection; Development; Electrocardiogram; Electrodes; Funding; Heart Atrium; Heart Diseases; Heart Rate; Heart failure; Human; Immersion Investigative Technique; Implant; Indiana; Institutes; Laboratory Research; Lead; Legal patent; Limb structure; Marketing; Measures; Methods; Modeling; Nerve; Neuromuscular Diseases; Patients; Peripheral Nervous System; Phase; Postoperative Period; Procedures; Recurrence; Research Project Grants; Risk; Signal Transduction; Sinus; Skin; Stratification; Structure of stellate ganglion; Subcutaneous Tissue; Techniques; Testing; Thoracotomy; Universities; Valsalva Maneuver; Ventricular Arrhythmia; Ventricular Fibrillation; Ventricular Tachycardia; Water; autonomic nerve; design; disease diagnosis; heart rate variability; human subject; improved; instrument; novel diagnostics; public health relevance; response; subcutaneous; sudden cardiac death; tool; volunteer

DESCRIPTION (provided by applicant): The broad and long-term objective of this research project is to use, develop and market an instrument for the simultaneous recording of sympathetic nerve activity (SNA) and electrocardiogram (ECG) using electrodes on the skin. This method (neuECG) was discovered in Dr. Chen's research laboratory at the Krannert Institute of Cardiology, and a patent application has been filed by Indiana University. Arrhythmotech LLC was developed to further advance this concept and we propose that neuECG has a significant commercial value by providing a new non-invasive tool for arrhythmia prediction and detection. Sympathetic tone is important in cardiac arrhythmogenesis. Heart rate variability analyses and microneurography recordings are standard techniques to assess sympathetic tone. However, these techniques have multiple limitations. The neuECG was developed to record ECG and nerve activity simultaneously on the skin of human subjects. In collaboration with Dr. Chen's lab, we have obtained strong preliminary results in human patients to document the successful recording of neuECG in normal volunteers and in patients with postoperative atrial fibrillation and electrical storm. In these preliminary studies, neuECG recording showed electrical signals consistent with SNA, and that the SNA correlated with heart rate acceleration, atrial fibrillation and ventricular arrhythmias. We propose that the neuECG may serve as a new diagnostic tool for the prediction of cardiac arrhythmias and sudden cardiac death. In addition, it may be helpful in the diagnosis of diseases involving the peripheral nervous system, such as neuromuscular diseases. In this Phase 1 application, we have designed two clinical studies to document the feasibility and utility of neuECG recording in normal volunteers and in patients with cardiac arrhythmias. Once this is complete, we will immediately apply for Phase 2 funding to commercialize the neuECG for human use. Specific Aim 1: To record simultaneous ECG and SNA in normal volunteers and correlate the nerve activity to heart rate. We will consent normal volunteers for this study. We will place ECG electrodes on the skin using standard limb lead and chest lead configurations. The signals are digitized and filtered to record ECG and SNA simultaneously. After baseline recordings, the patients will undergo 2-min cold water immersion test, followed by Valsalva maneuver. The data will be analyzed to test the hypothesis that it is feasible to simultaneously record SNA from the skin, and that SNA recordings correlate with heart rate acceleration in normal volunteers. Specific Aim 2: To record simultaneous ECG and SNA in patients with cardiac arrhythmias and correlate an increase in nerve activity to arrhythmia onset. We will perform continuous neuECG recording at the bedside in patients with recurrent cardiac arrhythmias. The data will be analyzed to determine if the SNA are present on the skin of the diseased patients, and if the SNA correlates with the onset of cardiac arrhythmias. The results will be used to test the hypothesis that a continuous neuECG recording is feasible in patients with heart diseases, and that SNA predicts the impending onset of cardiac arrhythmias.

描述（由申请人提供）：本研究项目的广泛和长期目标是使用、开发和销售一种仪器，用于使用皮肤上的电极同时记录交感神经活动（SNA）和心电图（ECG）。这种方法（neuECG）是在Krannert心脏病研究所的陈博士的研究实验室发现的，并已由印第安纳州大学提交了专利申请。心律失常技术有限责任公司的发展，以进一步推进这一概念，我们建议，neuECG具有显着的商业价值，提供了一种新的非侵入性工具，心律失常的预测和检测。交感神经紧张在心肌梗死中起重要作用。心率变异性分析和显微神经描记术记录是评估交感神经张力的标准技术。然而，这些技术具有多种局限性。neuECG被开发用于同时记录人类受试者皮肤上的ECG和神经活动。通过与Chen博士的实验室合作，我们在人类患者中获得了强有力的初步结果，记录了正常志愿者和术后房颤和电风暴患者的neuECG成功记录。在这些初步研究中，neuECG记录显示电信号与SNA一致，SNA与心率加速、房颤和室性心律失常相关。我们建议neuECG可能作为一种新的诊断工具，预测心律失常和心脏性猝死。此外，它可能有助于周围神经系统疾病的诊断 系统，如神经肌肉疾病。在该I期申请中，我们设计了两项临床研究，以记录neuECG记录在正常志愿者和心律失常患者中的可行性和实用性。一旦完成，我们将立即申请第二阶段资金，将neuECG商业化用于人类。具体目标1：同步记录正常志愿者的ECG和SNA，并将神经活动与心率相关联。我们将同意正常志愿者参与本研究。我们将使用标准肢体导联和胸导联配置将ECG电极放置在皮肤上。信号经过数字化和滤波处理，可同时记录ECG和SNA。基线记录后，患者将接受2分钟冷水浸泡试验，然后进行Valsalva动作。将对数据进行分析，以检验以下假设：同时记录皮肤SNA是可行的，SNA记录与正常志愿者的心率加速相关。具体目标二：同时记录心律失常患者的ECG和SNA，并将神经活动增加与心律失常发作相关联。我们将在复发性心律失常患者的床边进行连续neuECG记录。将对数据进行分析，以确定SNA是否存在于患病患者的皮肤上，以及SNA是否与心律失常的发作相关。结果将用于检验以下假设：连续neuECG记录在心脏病患者中是可行的，SNA预测即将发生的心律失常。