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Implantable Cardiac Defibrillators for the Prevention of Sudden Death in Patients With Cardiac Sarcoidosis

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT01013311
Collaborator
Stanford University (Other), Icahn School of Medicine at Mount Sinai (Other), Weill Medical College of Cornell University (Other), The Cleveland Clinic (Other)
10
Enrollment
1
Location
13
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to identify patients with cardiac sarcoidosis who may be at risk for sudden death.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Sarcoidosis is an inflammatory disease that can effect many organ systems. Patients with sarcoidosis involving the heart are at risk of sudden death related to ventricular arrythmias. However, we currently do not have a clinical test which can predict sudden cardiac death in these patients. While implantable cardioverter defibrillators(ICDs) can prevent sudden cardiac death in high risk patients, we do not know which patients will benefit from implantation of these devices. This clinical problem is important because we would like to identify patients at risk for sudden death who will benefit from ICD implantation. Additionally, we would like to avoid the risks to patients and financial expenses of inserting ICDs in patients who will not benefit from them.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Efficacy if Implantable Cardioverter Defibrillators for the Prevention of Sudden Death in Patients With Cardiac Sarcoidosis
    Study Start Date :
    Nov 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Cardiac Sarcoidosis

    Patients with Cardiac Sarcoidosis who had an ICD implanted

    Outcome Measures

    Primary Outcome Measures

    1. retrospective collection of demographic and clinical data on patients with cardiac sarcoidosis who had an ICD implanted to correlate clinical variables with ICD therapies for ventricular arrhythmias [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of Cardiac Sarcoidosis

    • Previous Implantable Cardioverter Defibrillator (ICD)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia Commonwealth University Richmond Virginia United States 23219

    Sponsors and Collaborators

    • Virginia Commonwealth University
    • Stanford University
    • Icahn School of Medicine at Mount Sinai
    • Weill Medical College of Cornell University
    • The Cleveland Clinic

    Investigators

    • Principal Investigator: Kenneth A Ellenbogen, MD, Virginia Commonweath University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT01013311
    Other Study ID Numbers:
    • HM12076
    First Posted:
    Nov 13, 2009
    Last Update Posted:
    Aug 24, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by Virginia Commonwealth University
    Implantable Cardioverter-Defibrillator (ICD)- pre-existing
    Additional relevant MeSH terms:
    Cardiomyopathies
    Sarcoidosis
    Death, Sudden

    Study Results

    No Results Posted as of Aug 24, 2017