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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonathan P Piccini, Duke University
ClinicalTrials.gov Identifier:
NCT00498524
First received: July 9, 2007
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • ICD Discharge [ Time Frame: Long-term follow up ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jonathan P Piccini, Assistant Professor of Medicine, Duke University
ClinicalTrials.gov Identifier: NCT00498524     History of Changes
Other Study ID Numbers: Pro00001258
Study First Received: July 9, 2007
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013