RECRUITING

Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2003-06
Study Completion:2029-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00733590

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of acute MI at least 4 weeks old
  2. * Non-ischemic LV dysfunction for at least 9 months
  3. * Who have an EF \< or = to 35%
  4. * Undergone ERI generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment.
  5. * Who have primary prevention implants.
  1. * ICD generator replacement for secondary prevention
  2. * Inability or unwillingness to provide valid informed consent
  3. * New York Heart Association Class IV heart failure
  4. * Patients with pre-existing Class 1 indications for pacemaker therapy.

Contacts and Locations

Study Contact

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

Principal Investigator

Katherine C Wu, MD
PRINCIPAL_INVESTIGATOR
Associate Professor of Medicine Johns Hopkins University

Study Locations (Sites)

Washington Hospital Center
Washington, District of Columbia, 20010
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Katherine C Wu, MD, PRINCIPAL_INVESTIGATOR, Associate Professor of Medicine Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2003-06
Study Completion Date2029-03

Study Record Updates

Study Start Date2003-06
Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

  • defibrillator, implanted
  • genomics
  • electrocardiography
  • electrophysiological study
  • proteomics

Additional Relevant MeSH Terms

  • Heart Failure, Congestive
  • Death, Sudden, Cardiac
  • Arrhythmia
  • Cardiomyopathies