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

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ClinicalTrials.gov Identifier: NCT01013311
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : August 24, 2017
Sponsor:
Collaborators:
Stanford University
Icahn School of Medicine at Mount Sinai
Weill Medical College of Cornell University
The Cleveland Clinic
Information provided by (Responsible Party):
Virginia Commonwealth University

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
Sarcoidosis of the Heart Cardiomyopathy

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 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 : November 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis
U.S. FDA Resources

Group/Cohort
Cardiac Sarcoidosis
Patients with Cardiac Sarcoidosis who had an ICD implanted



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 [ Time Frame: one year ]


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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:   Probability Sample
Study Population
Multi-center retrospective study. Up to 20 Elctrophysiologists at Academic Centers across North America
Criteria

Inclusion Criteria:

  • Diagnosis of Cardiac Sarcoidosis
  • Previous Implantable Cardioverter Defibrillator (ICD)

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): NCT01013311


Locations
United States, Virginia
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

Publications of Results:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01013311     History of Changes
Other Study ID Numbers: HM12076
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by Virginia Commonwealth University:
Implantable Cardioverter-Defibrillator (ICD)- pre-existing

Additional relevant MeSH terms:
Cardiomyopathies
Sarcoidosis
Death, Sudden
Heart Diseases
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Death
Pathologic Processes