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Risk of Life-Threatening Heart Rhythm Disturbances in Siblings (SIBFIB)
This study is enrolling participants by invitation only.
Study NCT00498524   Information provided by Duke University
First Received: July 9, 2007   Last Updated: February 3, 2008   History of Changes

July 9, 2007
February 3, 2008
July 2007
 
 
 
Complete list of historical versions of study NCT00498524 on ClinicalTrials.gov Archive Site
 
 
 
Risk of Life-Threatening Heart Rhythm Disturbances in Siblings
The Sibling Concordance for Implantable Cardioverter-Defibrillator Therapies in Ischemic Cardiomyopathy Study

The purpose of this study is to determine if heredity influences the risk of life-threatening heart rhythms (ventricular tachycardia and ventricular fibrillation) after heart attack (myocardial infarction).

Greater than 400,000 persons die suddenly each year in the US. The implantable cardioverter-defibrillator (ICD) has revolutionized the primary prevention of sudden cardiac death (SCD) following myocardial infarction (MI), however, risk stratification remains limited and rests solely on the identification of left ventricular dysfunction. The goal of this study is to determine if genetic factors influence the risk of ventricular arrhythmia remotely after myocardial infarction.

In order to determine if ventricular tachycardia or ventricular fibrillation remotely after MI is a heritable trait, we will conduct a family based case-control sibling study of patients who have received an ICD for ischemic cardiomyopathy. As a first step, we will utilize the GENECARD registry, an existing family linkage study of premature cardiovascular disease, to determine the prevalence of sibling concordance for ICD implantation following MI. Probands and siblings in the GENECARD study will be surveyed regarding their ICD history. The sibling recurrence risk ratio for ICD implantation following MI and subsequent ICD therapies will be used to estimate the sample size required to validate heritability, in a larger patient population. In the validation phase of this protocol, we will use a (1) single healthcare system database (Duke Cardiovascular Databank) and a (2) regional population-based registry, in order to determine concordance for ICD therapies. Patients who agree to participate and provide informed consent will be surveyed regarding their personal ICD history and that of their siblings. The prevalence of ICD therapies will be ascertained in the probands, siblings, and the overall cohort. Sibling concordance for ICD implantation and sibling concordance for subsequent appropriate ICD therapies will be used to determine the sibling recurrence risk ratio for appropriate ICD therapies remotely after MI.

 
Observational
Case Control, Retrospective
  • Defibrillators, Implantable
  • Myocardial Infarction
  • Tachycardias, Ventricular
Device: ICD
  • Sib who has received an ICD
  • Sib who has not received an ICD
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Enrolling by invitation
2000
February 2008
 

Inclusion Criteria:

  • patients must be alive
  • have a history of coronary artery disease / myocardial infarction
  • left ventricular ejection fraction ≤ 35%
  • received an implantable cardioverter- defibrillator

Exclusion Criteria:

  • nonischemic cardiomyopathy
  • Pre-identified hereditary arrhythmia syndrome (e.g. long QT syndrome, Brugada syndrome, etc)
  • left ventricular ejection fraction >35%
  • no implantable cardioverter-defibrillator
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00498524
Wesley G. Byerly, Pharm.D., Associate Dean, Research Support Services, Duke University Medical Center
Pro00001258
Duke University
Durham VA Medical Center
Principal Investigator: Patrick M Hranitzky, M.D. Duke University
Principal Investigator: Jonathan P Piccini, M.D. Duke University
Duke University
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP