Utility of Trans Telephonic Monitoring in the Detection of Silent Arrhythmias

转电话监测在无声心律失常检测中的应用

• 批准号: 7132412
• 负责人: KATHLEEN T HICKEY
• 金额: $ 8.05万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-15 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7132412
• 关键词: arrhythmia; clinical research

DESCRIPTION (provided by applicant): The primary aim of this feasibility study is to determine if a Cardiac Arrhythmia Trans telephonic EKG monitoring system (CAT) can be used to detect asymptomatic or "silent" arrhythmias in patients greater than or equal to 65 years of age with a history of hypertension (HTN) and heart failure (HF) and characterize their onset, frequency, and duration. The secondary aim is to examine the association between silent arrhythmias and quality of life (QoL). Atrial fibrillation (AF) is the most common arrhythmia and its prevalence increases with age, HTN, and HF. It also has a profound impact on QoL. Whether silent or symptomatic, AF can result in stroke. Detection of silent arrhythmias, especially silent AF, could prompt the initiation of anticoagulation that would decrease the occurrence of stroke, which is the third leading cause of death in the US. As treatment for HTN and HF continue to improve, combined with increased life expectancy, early arrhythmia identification strategies are urgently needed to predict who is at the highest risk for silent arrhythmias. Standard methods for detecting AF include 12-lead EKGs, 24-hour Holter recorders (HM) and non-auto-triggered memory loop recorders (MLR). MLRs are unable to automatically detect and capture silent arrhythmias since they require patient activation during symptoms. Auto-triggered MLRs (AT-MLR) have recently become available which automatically record arrhythmias, with or without associated symptoms, and the stored EKG data can then be transmitted trans telephonically (via phone) to a central monitoring station. A recently completed retrospective analysis has shown that AT-MLRs produced a higher yield of diagnostic events and an earlier time to diagnosis of silent arrhythmias as compared to HM or MLR. This study proposes a single-center, prospective consecutive series of 100 patients using a 14-day CAT monitoring period. At baseline and 6 months, cardiac clinical characteristics and risk factors will be collected from patients via physical exam and chart review, and the SF-36v2(TM) will be administered to determine if differences exist in perceived QoL in patients with silent AF. Information regarding AF frequency and duration will be quantified using the University of Toronto Atrial Fibrillation Scale (AFSS). Spearman's correlation will be used to assess the association between AF and changes in SF-36v2(TM) QoL scores between baseline and 6 months. The relationship between AF, demographic, and clinical characteristics will be determined using logistic regression analysis. All significant univariate variables will be entered into a multivariate logistic regression model. The results of this feasibility study could potentially justify development of a new screening mechanism for silent AF. If this study proves successful, a larger trial will be proposed to explore specific clinical variables, EKG characteristics, and treatment strategies to improve clinical care and QoL.

描述（由申请方提供）：本可行性研究的主要目的是确定心律失常跨电话EKG监测系统（CAT）是否可用于检测年龄≥ 65岁、有高血压（HTN）和心力衰竭（HF）病史的患者的无症状或“沉默”心律失常，并描述其发作、频率和持续时间。次要目的是检查无症状性心律失常与生活质量（QoL）之间的关系。心房颤动（AF）是最常见的心律失常，其患病率随着年龄、HTN和HF而增加。它也对QoL产生了深远的影响。无论是无症状的还是有症状的，房颤都可能导致中风。无症状性心律失常的检测，尤其是无症状性房颤，可以促使抗凝治疗的启动，从而减少卒中的发生，卒中是美国第三大死亡原因。随着HTN和HF治疗的不断改善，加上预期寿命的增加，迫切需要早期心律失常识别策略来预测谁是无症状心律失常的最高风险。检测房颤的标准方法包括12导联心电图、24小时霍尔特记录仪（HM）和非自动触发记忆环路记录仪（MLR）。MLR无法自动检测和捕获无症状心律失常，因为它们需要患者在症状期间激活。自动触发的MLR（AT-MLR）最近已经变得可用，其自动记录心律失常，具有或不具有相关症状，并且存储的EKG数据然后可以通过电话（经由电话）传输到中央监测站。最近完成的一项回顾性分析表明，与HM或MLR相比，AT-MLR产生的诊断事件率更高，诊断无症状性心律失常的时间更早。这项研究提出了一个单中心，前瞻性连续系列的100例患者使用14天的CAT监测期。在基线和6个月时，将通过体格检查和病历审查收集患者的心脏临床特征和风险因素，并使用SF-36 v2（TM）确定无症状AF患者的感知QoL是否存在差异。将使用多伦多大学房颤量表（AFSS）量化有关AF频率和持续时间的信息。将使用斯皮尔曼相关性评估AF与基线和6个月之间SF-36 v2（TM）QoL评分变化之间的相关性。将使用逻辑回归分析确定AF、人口统计学和临床特征之间的关系。将所有显著单变量变量输入多变量logistic回归模型。这项可行性研究的结果可能证明开发一种新的无症状房颤筛查机制是合理的。如果这项研究证明成功，将提出一项更大规模的试验，以探索特定的临床变量、EKG特征和治疗策略，以改善临床护理和生活质量。