Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498524
Status:
COMPLETED
Last Update Posted:
2012-12-07
First Post:
2007-07-09
Brief Title:
Risk of Life-threatening Heart Rhythm Disturbances in Siblings
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
The Sibling Concordance for Implantable Cardioverter-defibrillator Therapies in Ischemic Cardiomyopathy Study
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIBFIB
Brief Summary:
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
Detailed Description:
Greater than 400000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None