NCT00498524

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,047

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

7 months

First QC Date

July 9, 2007

Last Update Submit

December 6, 2012

Conditions

Defibrillators, ImplantableMyocardial InfarctionTachycardias, Ventricular

Keywords

implantable cardioverter-defibrillatorischemic cardiomyopathyventricular arrhythmiassibling concordance

Outcome Measures

Primary Outcomes (1)

  • ICD Discharge

    Long-term follow up

Study Arms (2)

1

Sib who has received an ICD

Device: ICD

2

Sib who has not received an ICD

Device: ICD

Interventions

ICDDEVICE

Received an ICD

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post-MI population with LV dysfunction and an implantable cardioverter-defibrillator.

You may qualify if:

  • patients must be alive
  • have a history of coronary artery disease / myocardial infarction
  • left ventricular ejection fraction ≤ 35%
  • received an implantable cardioverter- defibrillator

You may not qualify if:

  • nonischemic cardiomyopathy
  • Pre-identified hereditary arrhythmia syndrome (e.g. long QT syndrome, Brugada syndrome, etc)
  • left ventricular ejection fraction \>35%
  • no implantable cardioverter-defibrillator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center, Division of Cardiology - Electrophysiology Section

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Myocardial InfarctionTachycardia, Ventricular

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisTachycardiaArrhythmias, CardiacCardiac Conduction System Disease

Study Officials

  • Patrick M Hranitzky, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

  • Jonathan P Piccini, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

July 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

December 7, 2012

Record last verified: 2012-12

Locations

US(1)