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

This study is currently recruiting participants.
Verified August 2017 by Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733590
First Posted: August 13, 2008
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Maryland
Washington Hospital Center
Virginia Commonwealth University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University
  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 ]

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 ]

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

Estimated Enrollment: 1500
Actual 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
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
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


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

Locations
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)
Investigators
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 Submitted: August 11, 2008
First Posted: August 13, 2008
Last Update Posted: August 14, 2017
Last Verified: August 2017

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

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