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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Maryland
Washington Hospital Center
Virginia Commonwealth University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00733590
First received: August 11, 2008
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  Purpose

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 implantation of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD 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
Heart Failure, Congestive
Death, Sudden, Cardiac
Arrhythmia
Cardiomyopathies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSE-ICD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Arrhythmic Sudden Death defined as a shock from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause mortality, CV mortality, heart transplant, ICD explantation [ Time Frame: total period of observation in the study ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Whole blood drawn at 6 month intervals


Estimated Enrollment: 1200
Study Start Date: June 2003
Estimated Study Completion Date: December 2011
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation for primary prevention

Criteria

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 implantation of an FDA-approved ICD for primary prevention of SCD within 4 weeks of enrollment

Exclusion Criteria:

  • ICD implantation for secondary prevention
  • inability or unwillingness to provide valid informed consent
  • women < 50 years old with anatomic child-bearing potential who are unwilling to use contraceptives
  • New York Heart Association class IV heart failure
  • patients with permanent pacemakers or pre-existing Class 1 indications for pacemaker implantation
  • unsuccessful ICD implantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733590

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

Locations
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Zayd Eldadah, MD, PhD     202-877-7865     Zayd.Eldadah@Medstar.Net    
United States, Maryland
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    
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Stephen R Shorofsky, MD, PhD     800-492-5538     Sshorofs@medicine.umaryland.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
Investigators
Principal Investigator: Gordon F Tomaselli, MD Professor of Medicine Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

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

Responsible Party: Gordon F. Tomaselli, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00733590     History of Changes
Other Study ID Numbers: 02-12-16-06, 1RO1-HL091062-01
Study First Received: August 11, 2008
Last Updated: August 3, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013