Global Electrical Heterogeneity and Clinical Outcomes (GEHCO)

• ClinicalTrials.gov Identifier: NCT03210883
• Recruitment Status: Active, not recruiting
• First Posted: July 7, 2017
• Last Update Posted: September 16, 2020
• Sponsor: Larisa Tereshchenko
• Collaborator: American Heart Association
• Information provided by (Responsible Party): Larisa Tereshchenko, Oregon Health and Science University

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
Heart Failure; Implantable Defibrillator User; Ventricular Arrythmia

Study Design

• 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, 2021
• Estimated Study Completion Date: June 30, 2021

Groups and Cohorts

Outcome Measures

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)

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Waks JW, Hamilton C, Das S, Ehdaie A, Minnier J, Narayan S, Niebauer M, Raitt M, Tompkins C, Varma N, Chugh S, Tereshchenko LG. Improving sudden cardiac death risk stratification by evaluating electrocardiographic measures of global electrical heterogeneity and clinical outcomes among patients with implantable cardioverter-defibrillators: rationale and design for a retrospective, multicenter, cohort study. J Interv Card Electrophysiol. 2018 Jun;52(1):77-89. doi: 10.1007/s10840-018-0342-2. Epub 2018 Mar 14.

• 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
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases