Risk of Life-threatening Heart Rhythm Disturbances in Siblings

Myocardial Infarction Clinical Trial

— SIBFIB  

Official title:

The Sibling Concordance for Implantable Cardioverter-defibrillator Therapies in Ischemic Cardiomyopathy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498524
• Other study ID #: Pro00001258
• Status: Completed
• Phase: N/A
• First received: July 9, 2007
• Last updated: December 6, 2012
• Start date: July 2007
• Est. completion date: February 2008

Study information

• Verified date: December 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2047
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Defibrillators, Implantable
• Myocardial Infarction
• Tachycardia
• Tachycardia, Ventricular
• Tachycardias, Ventricular

Intervention

Device:
• ICD
Received an ICD
• ICD
Have not received an ICD

Locations

Country	Name	City	State
United States	Duke University Medical Center, Division of Cardiology - Electrophysiology Section	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICD Discharge		Long-term follow up	No