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Risk of Life-threatening Heart Rhythm Disturbances in Siblings (SIBFIB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498524
First Posted: July 10, 2007
Last Update Posted: December 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jonathan P Piccini, Duke University
  Purpose
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
Defibrillators, Implantable Myocardial Infarction Tachycardias, Ventricular Device: ICD

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Sibling Concordance for Implantable Cardioverter-defibrillator Therapies in Ischemic Cardiomyopathy Study

Resource links provided by NLM:


Further study details as provided by Jonathan P Piccini, Duke University:

Primary Outcome Measures:
  • ICD Discharge [ Time Frame: Long-term follow up ]

Enrollment: 2047
Study Start Date: July 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Sib who has received an ICD
Device: ICD
Received an ICD
2
Sib who has not received an ICD
Device: ICD
Have not received an ICD

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post-MI population with LV dysfunction and an implantable cardioverter-defibrillator.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498524


Locations
United States, North Carolina
Duke University Medical Center, Division of Cardiology - Electrophysiology Section
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Patrick M Hranitzky, M.D. Duke University
Principal Investigator: Jonathan P Piccini, M.D. Duke University
  More Information

Responsible Party: Jonathan P Piccini, Assistant Professor of Medicine, Duke University
ClinicalTrials.gov Identifier: NCT00498524     History of Changes
Other Study ID Numbers: Pro00001258
First Submitted: July 9, 2007
First Posted: July 10, 2007
Last Update Posted: December 7, 2012
Last Verified: December 2012

Keywords provided by Jonathan P Piccini, Duke University:
implantable cardioverter-defibrillator
ischemic cardiomyopathy
ventricular arrhythmias
sibling concordance

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiomyopathies
Tachycardia
Tachycardia, Ventricular
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arrhythmias, Cardiac