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

NCT00583297 | Completed DMC

• 2 other identifiers: CDX_000001ABCD
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventricular Tachycardia; Cardiovascular Diseases; Arrythmia; CVD

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Genotype and Pre-implant T-wave alternans status.

  two years as per original ABCD trial

Secondary Outcomes (1)

• Genotype and occurrence of appropriate cardioversion

  two years per original ABCD trial

Study Arms (1)

ABCD Subjects

The cohort will consist of original subjects of the ABCD trial who consent to participate in the genetic sub-study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Individuals who were not previously enrolled in the ABCD trial are not eligible for this genetic sub-study.

Sponsors & Collaborators

• CardioDx: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (2)

• 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. doi: 10.1196/annals.1380.018.

  PMID: 17132786 BACKGROUND

• 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. doi: 10.1016/j.jacc.2005.11.026. Epub 2005 Dec 15.

  PMID: 16412877 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and saliva.

MeSH Terms

Conditions

Tachycardia, Ventricular; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia; Heart Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Study Officials

• Amy J Sehnert, MD

  CardioDx, Inc.

  STUDY DIRECTOR

• Elizabeth Kaufman, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: February 22, 2018

Record last verified: 2017-10

Locations

US (1)