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

NCT01013311 | Completed

• 1 other identifier: HM12076
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sarcoidosis of the Heart; Cardiomyopathy

Keywords

Implantable Cardioverter-Defibrillator (ICD)- pre-existing

Outcome Measures

Primary Outcomes (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

Study Arms (1)

Cardiac Sarcoidosis

Patients with Cardiac Sarcoidosis who had an ICD implanted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multi-center retrospective study. Up to 20 Elctrophysiologists at Academic Centers across North America

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Related Publications (3)

• 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.

  PMID: 17905334 RESULT

• 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.

  PMID: 16018857 RESULT

• 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.

  PMID: 23002195 RESULT

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kenneth A Ellenbogen, MD

  Virginia Commonweath University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 13, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

US (1)