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Global Electrical Heterogeneity and Clinical Outcomes (GEHCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210883
Recruitment Status : Active, not recruiting
First Posted : July 7, 2017
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Larisa Tereshchenko, Oregon Health and Science University

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
Heart Failure Implantable Defibrillator User Ventricular Arrythmia

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Study Type : Observational
Actual Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Global Electrical Heterogeneity and Clinical Outcomes
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020



Primary Outcome Measures :
  1. Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock) [ Time Frame: 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 [ Time Frame: up to 15 years ]
    All-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy


Secondary Outcome Measures :
  1. sustained monomorphic ventricular tachycardia [ Time Frame: 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 [ Time Frame: up to 15 years ]
    sustained polymorphic ventricular tachycardia or ventricular fibrillation with appropriate ICD therapies (either antitachycardia pacing or ICD shock)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
retrospective records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210883


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Stanford University
Stanford, California, United States, 94305
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Veteran Administration Portland Healthcare System
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Larisa Tereshchenko
American Heart Association
Investigators
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Principal Investigator: Larisa G Tereshchenko, MD, PhD Oregon Health and Science University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Larisa Tereshchenko, Associate Professor of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03210883    
Other Study ID Numbers: STUDY00016754
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases