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

NCT ID: NCT01013311

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-12-31

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.

Conditions

Sarcoidosis of the Heart; Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cardiac Sarcoidosis

Patients with Cardiac Sarcoidosis who had an ICD implanted

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth A Ellenbogen, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonweath University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 17905334 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16018857 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23002195 (View on PubMed)

Other Identifiers

HM12076

Identifier Type: -

Identifier Source: org_study_id