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临床试验/NCT02814396
NCT02814396招募中不适用

The Application of Multichannel ECG Analytic System in Cardiovascular Diseases

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Composite cardiovascular outcome

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Composite cardiovascular outcome

时间窗: up to 5 years

The composite cardiovascular (CV) outcome will be any CV events (coronary, cerebral, or peripheral vascular diseases)

次要结局

  • With at least 1 cardiovascular risk factor.(up to 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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