Global Electrical Heterogeneity and Clinical Outcomes (GEHCO)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Implantable Defibrillator User; Ventricular Arrythmia

• Study Type: Observational
• Enrollment (Actual): 3471

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97239
      • Veteran Administration Portland Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

retrospective records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock)	Sustained ventricular tachyarrhythmia event with appropriate ICD therapy (either antitachycardia pacing or shock)	up to 15 years
Primary competing outcome: All-cause death without preceding sustained VT/VF with appropriate ICD therapy	All-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy	up to 15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sustained monomorphic ventricular tachycardia	Sustained monomorphic ventricular tachycardia with appropriate ICD therapies (either antitachycardia pacing or ICD shock)	up to 15 years
sustained polymorphic ventricular tachycardia / ventricular fibrillation	sustained polymorphic ventricular tachycardia or ventricular fibrillation with appropriate ICD therapies (either antitachycardia pacing or ICD shock)	up to 15 years

Collaborators and Investigators

• Sponsor: Larisa Tereshchenko
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Larisa G Tereshchenko, MD, PhD, Oregon Health and Science University

Publications and helpful links

General Publications

• 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.
• Waks JW, Haq KT, Tompkins C, Rogers AJ, Ehdaie A, Bender A, Minnier J, Dalouk K, Howell S, Peiris A, Raitt M, Narayan SM, Chugh SS, Tereshchenko LG. Competing risks in patients with primary prevention implantable cardioverter-defibrillators: Global Electrical Heterogeneity and Clinical Outcomes study. Heart Rhythm. 2021 Jun;18(6):977-986. doi: 10.1016/j.hrthm.2021.03.006. Epub 2021 Mar 6.
• Haq KT, Javadekar N, Tereshchenko LG. Detection and removal of pacing artifacts prior to automated analysis of 12-lead ECG. Comput Biol Med. 2021 Jun;133:104396. doi: 10.1016/j.compbiomed.2021.104396. Epub 2021 Apr 19.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): July 5, 2021
• Study Completion (Actual): July 5, 2021

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: STUDY00016754

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No