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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01013311
First Posted: November 13, 2009
Last Update Posted: August 24, 2017
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.
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
  Purpose
The purpose of this study is to identify patients with cardiac sarcoidosis who may be at risk for sudden death.

Condition
Sarcoidosis of the Heart Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy if Implantable Cardioverter Defibrillators for the Prevention of Sudden Death in Patients With Cardiac Sarcoidosis

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac Sarcoidosis
Patients with Cardiac Sarcoidosis who had an ICD implanted

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.
  Eligibility

Information from the National Library of Medicine

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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)
  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): 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
  More Information

Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01013311     History of Changes
Other Study ID Numbers: HM12076
First Submitted: November 10, 2009
First Posted: November 13, 2009
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