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Sponsors and Collaborators: |
Duke University Durham VA Medical Center |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00498524 |
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).
Condition | Intervention |
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Defibrillators, Implantable Myocardial Infarction Tachycardias, Ventricular |
Device: ICD |
Study Type: | Observational |
Study Design: | Case Control, Retrospective |
Official Title: | The Sibling Concordance for Implantable Cardioverter-Defibrillator Therapies in Ischemic Cardiomyopathy Study |
Estimated Enrollment: | 2000 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | February 2008 |
Groups/Cohorts | Assigned Interventions |
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1
Sib who has received an ICD
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Device: ICD
Received an ICD
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2
Sib who has not received an ICD
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Device: ICD
Have not received an ICD
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Post-MI population with LV dysfunction and an implantable cardioverter-defibrillator.
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Associate Dean, Research Support Services, Duke University Medical Center ( Wesley G. Byerly, Pharm.D. ) |
Study ID Numbers: | Pro00001258 |
Study First Received: | July 9, 2007 |
Last Updated: | February 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00498524 History of Changes |
Health Authority: | United States: Institutional Review Board |
implantable cardioverter-defibrillator ischemic cardiomyopathy ventricular arrhythmias sibling concordance |
Necrosis Heart Diseases Myocardial Ischemia Tachycardia Vascular Diseases Ischemia |
Infarction Cardiomyopathies Tachycardia, Ventricular Myocardial Infarction Arrhythmias, Cardiac |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Tachycardia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Tachycardia, Ventricular Myocardial Infarction Arrhythmias, Cardiac |