Genetic Substudy of the Alternans Before Cardioverter Defibrillator (ABCD) Trial - Full Text View

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	Intervention
Coronary Artery Disease Heart Failure Ventricular Tachycardia	Other: Blood Draw

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:

Genetics Home Reference related topics: catecholaminergic polymorphic ventricular tachycardia

MedlinePlus related topics: Arrhythmia Coronary Artery Disease Heart Diseases Heart Failure

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Genotype and occurrence of appropriate cardioversion for ventricular tachycardia or ventricular fibrillation [ Time Frame: two years per original ABCD trial ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Whole blood and saliva.

Estimated 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	Assigned Interventions
ABCD Subjects The cohort will consist of original subjects of the ABCD trial who consent to participate in the genetic sub-study	Other: Blood Draw No Intervention.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Wilson LD, Wan X, Rosenbaum DS. Cellular alternans: a mechanism linking calcium cycling proteins to cardiac arrhythmogenesis. Ann N Y Acad Sci. 2006 Oct;1080:216-34. Review.

Bloomfield DM, Bigger JT, Steinman RC, Namerow PB, Parides MK, Curtis AB, Kaufman ES, Davidenko JM, Shinn TS, Fontaine JM. Microvolt T-wave alternans and the risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. J Am Coll Cardiol. 2006 Jan 17;47(2):456-63. Epub 2005 Dec 15.

Responsible Party:	Amy Sehnert, MD, Director, Clinical R&D, CardioDx, Inc.
ClinicalTrials.gov Identifier:	NCT00583297 History of Changes
Other Study ID Numbers:	CDx_000001
Study First Received:	December 20, 2007
Last Updated:	June 6, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by CardioDx:

Arrhythmia
Heart Failure
T wave Alternans (TWA)

Implanted Cardioverter Defibrillator(ICD)
Biological Markers
Molecular Genetics

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Failure
Tachycardia
Tachycardia, Ventricular
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013