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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 10, 2009
First Posted Date November 13, 2009
Last Update Posted Date August 24, 2017
Study Start Date November 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Multi-center retrospective study. Up to 20 Elctrophysiologists at Academic Centers across North America
Condition
  • Sarcoidosis of the Heart
  • Cardiomyopathy
Intervention Not Provided
Study Groups/Cohorts Cardiac Sarcoidosis
Patients with Cardiac Sarcoidosis who had an ICD implanted
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 23, 2017)
10
Original Estimated Enrollment
 (submitted: November 12, 2009)
50
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of Cardiac Sarcoidosis
  • Previous Implantable Cardioverter Defibrillator (ICD)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01013311
Other Study ID Numbers HM12076
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor Virginia Commonwealth University
Collaborators
  • Stanford University
  • Icahn School of Medicine at Mount Sinai
  • Weill Medical College of Cornell University
  • The Cleveland Clinic
Investigators
Principal Investigator: Kenneth A Ellenbogen, MD Virginia Commonweath University
PRS Account Virginia Commonwealth University
Verification Date August 2017