Genetic Substudy of the Alternans Before Cardioverter Defibrillator (ABCD) Trial

Identifying Genetic Markers That Predict Microvolt T-wave Alternans Status and Arrhythmia Risk in Patients With Ischemic Heart Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00583297

Acronym

ABCD

Enrollment

400

Registered

2007-12-31

Start date

2007-01-31

Completion date

2009-12-31

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrythmia, Cardiovascular Diseases, CVD, Ventricular Tachycardia

Keywords

Arrhythmia, Heart Failure, T-wave Alternans, Implanted Cardioverter Defibrillator, Biological Markers, Molecular Genetics, Corus CAD, ASGES, Age/Sex/Gene Expression Score, Gene Expression, GES, CVD, Precision Medicine, Sudden Cardiac Death, Electrophysiology Study, Cardiovascular Disease, ICD, EPS, SCD, TWA

Brief summary

The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in patients with ischemic heart disease, left ventricular dysfunction, and non-sustained tachycardia. The purpose of the ABCD Genetic sub-study is to identify genetic markers that predict TWA status and arrhythmia risk in this same population.

Detailed description

The primary objective of this study is to test the hypothesis that therapy directed primarily by a T wave alternans (TWA) test, measured non-invasively during exercise, is equivalent to therapy directed by an electrophysiological study (EPS) in predicting spontaneous ventricular tachyarrhythmic events (VTEs) in patients with ischemic heart disease, left ventricular dysfunction, and asymptomatic non-sustained ventricular tachycardia (NSVT). In the absence of any previous life-threatening ventricular arrhythmia (i.e., for primary prevention), ICD implantation is currently indicated in patients with ischemic heart disease, left ventricular dysfunction, asymptomatic non-sustained ventricular tachycardia, and a positive EPS. The objective of this study is to demonstrate that a TWA test directed therapy is equivalent to EPS directed therapy in guiding ICD implantation for the purpose of primary prevention of sudden cardiac death (SCD) in patients with ischemic heart disease, left ventricular dysfunction, and asymptomatic non-sustained ventricular tachycardia.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects previously enrolled in the ABCD trial sponsored by St. Jude Medical (ClinicalTrials.gov Identifier NCT00187291) * patients with ischemic heart disease * left ventricular ejection fraction (LVEF) \< 40% * non-sustained ventricular tachycardia

Exclusion criteria

Individuals who were not previously enrolled in the ABCD trial are not eligible for this genetic sub-study.

Design outcomes

Primary

Measure	Time frame	Description
Genotype and Pre-implant T-wave alternans status.	two years as per original ABCD trial	Genotype and Pre-implant T-wave alternans status.

Secondary

Measure	Time frame	Description
Genotype and occurrence of appropriate cardioversion	two years per original ABCD trial	Genotype and occurrence of appropriate cardioversion for ventricular tachycardia or ventricular fibrillation

Countries

United States

Outcome results