The Application of Multichannel ECG Analytic System in Cardiovascular Diseases

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02814396
Collaborator
(none)
5,000
1
129
38.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Application of Multichannel ECG Analytic System in Cardiovascular Diseases
    Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Composite cardiovascular outcome [up to 5 years]

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

    Secondary Outcome Measures

    1. With at least 1 cardiovascular risk factor. [up to 5 years]

      no evidence of atherosclerotic vascular diseases,with at least 1 cardiovascular risk factor.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients older than 20 years old.

    • with suspected arrhythmia or cardiovascular diseases.

    Exclusion criteria

    • NO

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NTUH Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Chau C WU, M.D.,Ph.D., chauchungwu@ntu.edu.tw

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02814396
    Other Study ID Numbers:
    • 201207070RIC
    First Posted:
    Jun 27, 2016
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 28, 2022