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

This study has been completed.
Sponsor:
Information provided by:
CardioDx
ClinicalTrials.gov Identifier:
NCT00583297
First received: December 20, 2007
Last updated: June 6, 2011
Last verified: June 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 26, 2014