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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
University of Maryland
Washington Hospital Center
Virginia Commonwealth University
Information provided by:
Johns Hopkins University Identifier:
First received: August 11, 2008
Last updated: August 3, 2009
Last verified: August 2009

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

Heart Failure, Congestive
Death, Sudden, Cardiac

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:

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


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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00733590

Contact: Barbara Butcher, BSN 443 287-3472

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   
Contact: Gordon Tomaselli, MD    410 955-2774   
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Stephen R Shorofsky, MD, PhD    800-492-5538   
United States, Virginia
Virginia Commonwealth University School of Medicine Recruiting
Richmond, Virginia, United States, 23298
Contact: Kenneth Ellenbogen, MD    804-828-7576   
Sponsors and Collaborators
Johns Hopkins University
University of Maryland
Washington Hospital Center
Virginia Commonwealth University
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 Identifier (NCT Number):
Responsible Party: Gordon F. Tomaselli, Johns Hopkins University 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
electrophysiological study

Additional relevant MeSH terms:
Death, Sudden
Death, Sudden, Cardiac
Heart Failure
Cardiovascular Diseases
Heart Arrest
Heart Diseases
Pathologic Processes processed this record on November 20, 2014