Clinical trial NCT00498524: Risk of Life-threatening Heart Rhythm Disturbances in Siblings
Official title: The Sibling Concordance for Implantable Cardioverter-defibrillator Therapies in Ischemic Cardiomyopathy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Defibrillators, Implantable
Myocardial Infarction
Tachycardias, Ventricular
Keywords: implantable cardioverter-defibrillator
ischemic cardiomyopathy
ventricular arrhythmias
sibling concordance
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2007-07-10
Enrollment: 2047
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-MI population with LV dysfunction and an implantable cardioverter-defibrillator.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: ICD Discharge
timeFrame: Long-term follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center, Division of Cardiology - Electrophysiology Section
state: North Carolina
Study officials:
affiliation: Duke University
name: Patrick M Hranitzky, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Jonathan P Piccini, M.D.
role: PRINCIPAL_INVESTIGATOR
References: