Clinical trial NCT01013311: Implantable Cardiac Defibrillators for the Prevention of Sudden Death in Patients With Cardiac Sarcoidosis
Official title: Efficacy if Implantable Cardioverter Defibrillators for the Prevention of Sudden Death in Patients With Cardiac Sarcoidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis of the Heart
Cardiomyopathy
Keywords: Implantable Cardioverter-Defibrillator (ICD)- pre-existing
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Icahn School of Medicine at Mount Sinai
name: Weill Medical College of Cornell University
name: The Cleveland Clinic
First posted: 2009-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multi-center retrospective study. Up to 20 Elctrophysiologists at Academic Centers across North America

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

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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonweath University
name: Kenneth A Ellenbogen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.hrthm.2007.06.006. Epub 2007 Jun 16.
citation: 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. doi: 10.1016/j.amjcard.2005.03.059.
citation: 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.