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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Stanford University
Mount Sinai School of Medicine
Weill Medical College of Cornell University
The Cleveland Clinic
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01013311
First received: November 10, 2009
Last updated: April 10, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013311

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
Stanford University
Mount Sinai School of Medicine
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
Study First Received: November 10, 2009
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Implantable Cardioverter-Defibrillator (ICD)- pre-existing

Additional relevant MeSH terms:
Death, Sudden
Sarcoidosis
Cardiomyopathies
Death
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014