Genetic Substudy of the Alternans Before Cardioverter Defibrillator (ABCD) Trial
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/24/2018 |
| Start Date: | January 2007 |
| End Date: | December 2009 |
Identifying Genetic Markers That Predict Microvolt T-wave Alternans Status and Arrhythmia Risk in Patients With Ischemic Heart Disease
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.
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.
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.
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.
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.
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