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Risk of Life-threatening Heart Rhythm Disturbances in Siblings

NCT ID: NCT00498524

Last Updated: 2012-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2047 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Defibrillators, Implantable Myocardial Infarction Tachycardias, Ventricular

Keywords

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implantable cardioverter-defibrillator ischemic cardiomyopathy ventricular arrhythmias sibling concordance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Sib who has received an ICD

ICD

Intervention Type DEVICE

Received an ICD

2

Sib who has not received an ICD

ICD

Intervention Type DEVICE

Have not received an ICD

Interventions

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ICD

Received an ICD

Intervention Type DEVICE

ICD

Have not received an ICD

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Jonathan P Piccini

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick M Hranitzky, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Jonathan P Piccini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center, Division of Cardiology - Electrophysiology Section

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00001258

Identifier Type: -

Identifier Source: org_study_id