Risk of Life-threatening Heart Rhythm Disturbances in Siblings (SIBFIB)
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).
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||The Sibling Concordance for Implantable Cardioverter-defibrillator Therapies in Ischemic Cardiomyopathy Study|
- ICD Discharge [ Time Frame: Long-term follow up ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Sib who has received an ICD
Received an ICD
Sib who has not received an ICD
Have not received an ICD
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498524
|United States, North Carolina|
|Duke University Medical Center, Division of Cardiology - Electrophysiology Section|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Patrick M Hranitzky, M.D.||Duke University|
|Principal Investigator:||Jonathan P Piccini, M.D.||Duke University|