Global Electrical Heterogeneity and Clinical Outcomes

NCT03210883 | Completed

• 1 other identifier: STUDY00016754
• Study Type: observational
• Target: 3,471
• Locations: 1 country
• Sites: 6

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.

Conditions

Heart Failure; Implantable Defibrillator User; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• sustained monomorphic ventricular tachycardia

  up to 15 years

• sustained polymorphic ventricular tachycardia / ventricular fibrillation

  up to 15 years

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Larisa Tereshchenko: lead
• American Heart Association: collaborator

Study Sites (6)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Veteran Administration Portland Healthcare System

Portland, Oregon, 97239, United States

Location

Related Publications (4)

• 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.

  PMID: 29541969 BACKGROUND

• 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.

  PMID: 33684549 RESULT

• 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.

  PMID: 33872969 RESULT

• Tereshchenko LG, Waks JW, Tompkins C, Rogers AJ, Ehdaie A, Henrikson CA, Dalouk K, Raitt M, Kewalramani S, Kattan MW, Santangeli P, Wilkoff BW, Kapadia SR, Narayan SM, Chugh SS. Competing risks of monomorphic vs. non-monomorphic ventricular arrhythmias in primary prevention implantable cardioverter-defibrillator recipients: Global Electrical Heterogeneity and Clinical Outcomes (GEHCO) study. Europace. 2024 Jun 3;26(6):euae127. doi: 10.1093/europace/euae127.

  PMID: 38703375 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Larisa G Tereshchenko, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 7, 2017
• Study Start: July 1, 2017
• Primary Completion: July 5, 2021
• Study Completion: July 5, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-07

Locations

US (6)