Clinical trial NCT03210883: Global Electrical Heterogeneity and Clinical Outcomes
Official title: Global Electrical Heterogeneity and Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Implantable Defibrillator User
Ventricular Arrythmia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2017-07-07
Enrollment: 3471
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: retrospective records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications

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.


Eligibility 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.

Primary outcomes:
measure: Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock)
timeFrame: up to 15 years
measure: Primary competing outcome: All-cause death without preceding sustained VT/VF with appropriate ICD therapy
timeFrame: up to 15 years
Secondary outcomes:
measure: sustained monomorphic ventricular tachycardia
timeFrame: up to 15 years
measure: sustained polymorphic ventricular tachycardia / ventricular fibrillation
timeFrame: up to 15 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Portland
country: United States
facility: Veteran Administration Portland Healthcare System
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Larisa G Tereshchenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.