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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583297
First Posted: December 31, 2007
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CardioDx
  Purpose
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.

Condition
Ventricular Tachycardia Cardiovascular Diseases Arrythmia CVD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying Genetic Markers That Predict Microvolt T-wave Alternans Status and Arrhythmia Risk in Patients With Ischemic Heart Disease

Resource links provided by NLM:


Further study details as provided by CardioDx:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA
Whole blood and saliva.

Enrollment: 400
Study Start Date: January 2007
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
ABCD Subjects
The cohort will consist of original subjects of the ABCD trial who consent to participate in the genetic sub-study

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population for the ABCD genetic sub-study includes all living individuals currently enrolled in the ABCD trial (total study enrollment=629; 566 analyzed in the trial) Participants of the ABCD trial underwent TWA and EPS testing to determine their risk for ventricular arrhythmia and most have received an implantable cardioverter defibrillator (ICD). The ABCD trial collected extensive longitudinal clinical data including medical and medication histories, incidence of ventricular arrhythmias, defibrillator shocks, other cardiovascular events, and mortality.
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583297


Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
CardioDx
Investigators
Study Director: Amy J Sehnert, MD CardioDx, Inc.
Principal Investigator: Elizabeth Kaufman, MD MetroHealth Medical Center
  More Information

Publications:
Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT00583297     History of Changes
Other Study ID Numbers: CDX_000001
ABCD ( Other Identifier: CardioDx )
First Submitted: December 20, 2007
First Posted: December 31, 2007
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by CardioDx:
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

Additional relevant MeSH terms:
Cardiovascular Diseases
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes