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Completed

NCT Number: NCT00583297

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

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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Arrythmia CVD Cardiac Conduction System Disease Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Genotype and Pre-implant T-wave alternans status.

    Time frame: two years as per original ABCD trial

    Genotype and Pre-implant T-wave alternans status.

Secondary outcomes

  1. Genotype and occurrence of appropriate cardioversion

    Time frame: two years per original ABCD trial

    Genotype and occurrence of appropriate cardioversion for ventricular tachycardia or ventricular fibrillation

Sponsors and collaborators

Lead sponsor

CardioDx

Industry

Registry information

Official study title

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

Acronym: ABCD

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Dec 31, 2007
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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