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The Application of Multichannel ECG Analytic System in Cardiovascular Diseases

2022年3月24日 更新者:National Taiwan University Hospital
Cardiovascular disease (CVD) is the leading cause of death worldwide. Most individuals with CVD show no evidence of disease for decades as the disease progresses before the first onset of symptoms, often a "sudden" heart attack, finally arises. The spatial repolarization heterogeneity within the ventricular myocardium had been proposed to represent the function of the heart in health and disease. Greater than normal levels of repolarization dispersion may allow early diagnosis of CVD. There is a growing interest in the characteristic features of ventricular repolarization that leads to lethal ventricular arrhythmia even with the use of non-antiarrhythmic drugs. The recovery time dispersion may reflect a repolarization heterogeneity leading to lethal ventricular arrhythmia. Previously, the investigators had utilized a 64-channel low-TC SQUID MCG device to develop and verify 2 parameters, so called smooth index of QTc (SIQTc) and T wave propagation (TWP), to accurately detect and localize the myocardial ischemia. Recently Nakai, et al. reported that a newly developed 187-ch signal-averaged vector-projected ECG (187-ch SAVP-ECG) could evaluate low-amplitude high-frequency potentials and repolarization heterogeneity. In this project, the investigators'll try to modify and improve the spatial resolution of ECG signals from a Self-built-in multichannel ECG system with a newly developed algorithm, and also try to derive the SIQTc and TWP from this system, for early detection of CVD. The investigators intend to prove the concept that this newly developed multichannel ECG system could efficiently detect or diagnose CVD with acceptable sensitivity and specificity, and in a portable way.

研究概览

地位

招聘中

详细说明

Cardiovascular disease (CVD) is the leading cause of death worldwide. Most individuals with CVD show no evidence of disease for decades as the disease progresses before the first onset of symptoms, often a "sudden" heart attack, finally arises. The spatial repolarization heterogeneity within the ventricular myocardium had been proposed to represent the function of the heart in health and disease. Greater than normal levels of repolarization dispersion may allow early diagnosis of CVD. There is a growing interest in the characteristic features of ventricular repolarization that leads to lethal ventricular arrhythmia even with the use of non-antiarrhythmic drugs. The recovery time dispersion may reflect a repolarization heterogeneity leading to lethal ventricular arrhythmia. Although cheap and convenient, the traditional 12-leads electrocardiogram (ECG) is frequently normal at rest in such patients. The quantification of repolarization heterogeneity with ECG, QT dispersion, has some methodological limitations and has been abandoned in daily practice. Many studies have shown that body surface potential mapping (BSPM) contains more diagnostic and prognostic information than that elicited from a 12-lead ECG. The BSPM and magnetocardiogram (MCG) are two new developed recording methods, and provide higher spatial resolution than traditional ECG signals but with the disadvantages of high cost and huge volume. It is impossible to be used in a portable way. Previously, the investigators had utilized a 64-channel low-TC SQUID MCG device to develop and verify 2 parameters, so called smooth index of QTc (SIQTc) and T wave propagation (TWP), to accurately detect and localize the myocardial ischemia. Recently Nakai, et al. reported that a newly developed 187-ch signal-averaged vector-projected ECG (187-ch SAVP-ECG) could evaluate low-amplitude high-frequency potentials and repolarization heterogeneity. In this project, the investigators'll try to modify and improve the spatial resolution of ECG signals from a Self-built-in multichannel ECG system with a newly developed algorithm, and also try to derive the SIQTc and TWP from this system, for early detection of CVD. The investigators intend to prove the concept that this newly developed multichannel ECG system could efficiently detect or diagnose CVD with acceptable sensitivity and specificity, and in a portable way.

研究类型

观察性的

注册 (预期的)

5000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Wan T Ke
  • 电话号码:88558 886-223123456
  • 邮箱t87134@gmail.com

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

Space ventricular repolarization within the proposal does not have to represent functions in heart health and disease. Repolarization dispersion higher than normal levels may allow early diagnosis of CVD.

The BSPM and magnetic diagram (MCG) is a newly developed method for both records, and provide higher spatial resolution than conventional ECG signal but has a high cost and bulky shortcomings. It is impossible in a portable manner. Previously, the investigators have used a 64-channel low TC SQUID MCG equipment to develop and validate two parameters, the so-called QT interval (SIQTc) and T wave propagation (TWP) smoothness index, accurate detection and localization of myocardial ischemia blood.

描述

Inclusion Criteria:

  • Patients older than 20 years old.
  • with suspected arrhythmia or cardiovascular diseases.

Exclusion criteria

  • NO

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
复合心血管结果
大体时间:长达 5 年
复合心血管 (CV) 结果将是任何 CV 事件(冠状动脉、大脑或外周血管疾病)
长达 5 年

次要结果测量

结果测量
措施说明
大体时间
至少有 1 个心血管危险因素。
大体时间:长达 5 年
没有动脉粥样硬化性血管疾病的证据,至少有 1 个心血管危险因素。
长达 5 年

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Chau C WU, M.D.,Ph.D.、chauchungwu@ntu.edu.tw

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年1月1日

初级完成 (预期的)

2023年10月1日

研究完成 (预期的)

2023年10月1日

研究注册日期

首次提交

2016年6月23日

首先提交符合 QC 标准的

2016年6月23日

首次发布 (估计)

2016年6月27日

研究记录更新

最后更新发布 (实际的)

2022年3月28日

上次提交的符合 QC 标准的更新

2022年3月24日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 201207070RIC

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Multichannel ECG System的临床试验

  • University Hospital, Grenoble
    Clinical Investigation Centre for Innovative Technology Network; University Grenoble Alps; TIM...
    完全的
    怀孕自愿受试者的 ECG-PCG-CTG 采集
    法国
  • Avidhrt Inc.
    Michigan State University; ASCENSION SACRED HEART; Spring Arbor University
    尚未招聘
    AF 和非 AF 用户的 ECG 电极类型信号质量的等效性
  • Azienda Ospedaliero Universitaria di Sassari
    招聘中
    ECG 上的左束支传导阻滞 (LBBB)
    意大利
  • Tampere University
    VTT Technical Research Centre of Finland; Tays Heart Hospital; GE Healthcare Finland Ltd; Fimlab... 和其他合作者
    完全的
    心肌梗塞 | 冠状动脉疾病 | 心房颤动 | 心室颤动 | 室性心动过速 | 房室传导阻滞 | 心房震颤 | 室性心律失常 | 心律失常 | ECG 电交替
    芬兰
3
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