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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Johns Hopkins University
Sponsor:
Collaborators:
University of Maryland
Washington Hospital Center
Virginia Commonwealth University
Information provided by (Responsible Party):
Gordon F. Tomaselli, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00733590
First received: August 11, 2008
Last updated: January 27, 2015
Last verified: January 2015
  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 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
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)

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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

Biospecimen Retention:   Samples With DNA

Whole blood drawn at 6-12 month intervals


Estimated Enrollment: 1500
Study Start Date: June 2003
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
  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 their first ICD generator replacement 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 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
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 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, Chief of Cardiology JHU, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00733590     History of Changes
Other Study ID Numbers: NA_00045142, 5R01HL091062
Study First Received: August 11, 2008
Last Updated: January 27, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on February 27, 2015