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

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
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 Design

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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

Groups and Cohorts

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

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

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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

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Principal Investigator:	Kenneth A Ellenbogen, MD	Virginia Commonweath University

More Information

Publications of Results:

Banba K, Kusano KF, Nakamura K, Morita H, Ogawa A, Ohtsuka F, Ogo KO, Nishii N, Watanabe A, Nagase S, Sakuragi S, Ohe T. Relationship between arrhythmogenesis and disease activity in cardiac sarcoidosis. Heart Rhythm. 2007 Oct;4(10):1292-9. Epub 2007 Jun 16.

Aizer A, Stern EH, Gomes JA, Teirstein AS, Eckart RE, Mehta D. Usefulness of programmed ventricular stimulation in predicting future arrhythmic events in patients with cardiac sarcoidosis. Am J Cardiol. 2005 Jul 15;96(2):276-82.

Kron J, Sauer W, Schuller J, Bogun F, Crawford T, Sarsam S, Rosenfeld L, Mitiku TY, Cooper JM, Mehta D, Greenspon AJ, Ortman M, Delurgio DB, Valadri R, Narasimhan C, Swapna N, Singh JP, Danik S, Markowitz SM, Almquist AK, Krahn AD, Wolfe LG, Feinstein S, Ellenbogen KA. Efficacy and safety of implantable cardiac defibrillators for treatment of ventricular arrhythmias in patients with cardiac sarcoidosis. Europace. 2013 Mar;15(3):347-54. doi: 10.1093/europace/eus316. Epub 2012 Sep 21.

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Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT01013311
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:

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Cardiomyopathies Sarcoidosis Death, Sudden Heart Diseases Cardiovascular Diseases	Lymphoproliferative Disorders Lymphatic Diseases Death Pathologic Processes

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