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

Completed

• Conditions: Cardiovascular Diseases; Arrythmia; CVD; Ventricular Tachycardia

• Registration Number: NCT00583297
• Lead Sponsor: CardioDx

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-31
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Status Verified: 2017-10
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genotype and Pre-implant T-wave alternans status.	two years as per original ABCD trial	Genotype and Pre-implant T-wave alternans status.

Secondary Outcome Measures

Name	Time	Method
Genotype and occurrence of appropriate cardioversion	two years per original ABCD trial	Genotype and occurrence of appropriate cardioversion for ventricular tachycardia or ventricular fibrillation

Trial Locations

Locations (1)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States