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OpenTrials
Completed

NCT Number: NCT01013311

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

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

Completed

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Key information

Conditions

Sarcoidosis of the Heart Cardiomyopathies Cardiomyopathy Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • Stanford University
  • The Cleveland Clinic
  • Weill Medical College of Cornell University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2009
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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