GEHCO: Global Electrical Heterogeneity and Clinical Outcomes

Sponsor
Larisa Tereshchenko (Other)
Overall Status
Completed
CT.gov ID
NCT03210883
Collaborator
American Heart Association (Other)
3,471
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Study Details

Study Description

Brief Summary

This retrospective multicenter cohort will validate an independent association of electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD, and will validate and re-calibrate GEH ECG risk score for prediction of sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3471 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Global Electrical Heterogeneity and Clinical Outcomes
    Actual Study Start Date :
    Jul 1, 2017
    Actual Primary Completion Date :
    Jul 5, 2021
    Actual Study Completion Date :
    Jul 5, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock) [up to 15 years]

      Sustained ventricular tachyarrhythmia event with appropriate ICD therapy (either antitachycardia pacing or shock)

    2. Primary competing outcome: All-cause death without preceding sustained VT/VF with appropriate ICD therapy [up to 15 years]

      All-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy

    Secondary Outcome Measures

    1. sustained monomorphic ventricular tachycardia [up to 15 years]

      Sustained monomorphic ventricular tachycardia with appropriate ICD therapies (either antitachycardia pacing or ICD shock)

    2. sustained polymorphic ventricular tachycardia / ventricular fibrillation [up to 15 years]

      sustained polymorphic ventricular tachycardia or ventricular fibrillation with appropriate ICD therapies (either antitachycardia pacing or ICD shock)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications
    Exclusion Criteria:
    • absent baseline pre-implant digital ECG;

    • missing data on clinical predictors and covariates;

    • missing ICD programming data (including number of intervals to detect [NID] or time to detect, number of detection zones, heart rate for each detection zone, and anti-tachycardia pacing [ATP] programming);

    • missing outcomes data.

    • records of patients with inherited channelopathies (e.g. long QT syndrome, Brugada syndrome), inherited cardiomyopathies (e.g. hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy), and congenital heart disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048
    2 Stanford University Stanford California United States 94305
    3 University of Colorado Aurora Colorado United States 80045
    4 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    5 Oregon Health and Science University Portland Oregon United States 97239
    6 Veteran Administration Portland Healthcare System Portland Oregon United States 97239

    Sponsors and Collaborators

    • Larisa Tereshchenko
    • American Heart Association

    Investigators

    • Principal Investigator: Larisa G Tereshchenko, MD, PhD, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Larisa Tereshchenko, Associate Professor of Medicine, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT03210883
    Other Study ID Numbers:
    • STUDY00016754
    First Posted:
    Jul 7, 2017
    Last Update Posted:
    Jul 8, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 8, 2021