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Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)

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ClinicalTrials.gov Identifier: NCT00733590
Recruitment Status : Recruiting
First Posted : August 13, 2008
Last Update Posted : August 14, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at high risk of sudden cardiac death (SCD). Such information may be used to better define patients most likely to benefit from replacement of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD pulse generator replacement for primary prevention of SCD (PROSe-ICD) was established to :

  1. to gain a better understanding of the biological mechanisms that predispose to SCD
  2. to develop readily determined clinical, electrocardiographic, genetic and blood protein markers identify patients with an increased risk of dying suddenly

Condition or disease
Heart Failure, Congestive Death, Sudden, Cardiac Arrhythmia Cardiomyopathies

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)
Actual Study Start Date : June 2003
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Arrhythmic Sudden Death defined as a therapy from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. All cause mortality, CV mortality, heart transplant, LVAD, and ICD explantation or ICD Disabled [ Time Frame: Total period of observation in the study ]

Biospecimen Retention:   Samples With DNA
Whole blood drawn at 6-12 month intervals

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ischemic or non-ischemic cardiomyopathy undergoing their first ICD generator replacement for primary prevention.

Inclusion Criteria:

  • History of acute MI at least 4 weeks old
  • Non-ischemic LV dysfunction for at least 9 months
  • Who have an EF < or = to 35%
  • Undergone first ERI generator replacement of an FDA-approved ICD for primary prevention of SCD within 12 months of enrollment

Exclusion Criteria:

  • ICD generator replacement for secondary prevention
  • Inability or unwillingness to provide valid informed consent
  • New York Heart Association Class IV heart failure
  • Patients with pre-existing Class 1 indications for pacemaker therapy.
  • CRT-D devices.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733590

Contact: Barbara Butcher, BSN 443 287-3472 bbutche1@jhmi.edu

United States, District of Columbia
Washington Hospital Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Zayd Eldadah, MD, PhD    202-877-7865    Zayd.Eldadah@Medstar.Net   
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Stephen R Shorofsky, MD, PhD    800-492-5538    Sshorofs@medicine.umaryland.edu   
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Barbara Butcher, BSN    443-287-3472    bbutche1@jhmi.edu   
Contact: Gordon Tomaselli, MD    410 955-2774    gtomasel@jhmi.edu   
United States, Virginia
Virginia Commonwealth University School of Medicine Recruiting
Richmond, Virginia, United States, 23298
Contact: Kenneth Ellenbogen, MD    804-828-7576    kellenbogen@pol.net   
Sponsors and Collaborators
Johns Hopkins University
University of Maryland
Washington Hospital Center
Virginia Commonwealth University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Gordon F Tomaselli, MD Professor of Medicine Johns Hopkins University
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00733590     History of Changes
Other Study ID Numbers: NA_00045142
5R01HL091062 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
defibrillator, implanted
electrophysiological study

Additional relevant MeSH terms:
Heart Failure
Death, Sudden, Cardiac
Death, Sudden
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest