Myocardial Infarction Clinical Trial
Official title:
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.
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Observational Model: Case Control, Time Perspective: Retrospective
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