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

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• History of acute MI at least 4 weeks old

• Non-ischemic LV dysfunction for at least 9 months

• Who have an ejection fraction (EF) \< or = to 35%

• Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment.

• Who have primary prevention implants.

Locations
United States
Washington, D.c.
Washington Hospital Center
RECRUITING
Washington D.c.
Maryland
Johns Hopkins University School of Medicine
RECRUITING
Baltimore
University of Maryland Medical Center
RECRUITING
Baltimore
Virginia
Virginia Commonwealth University School of Medicine
RECRUITING
Richmond
Contact Information
Primary
Katherine Wu, MD
kwu@jhmi.edu
410-502-7283
Time Frame
Start Date: 2003-06
Estimated Completion Date: 2029-03
Participants
Target number of participants: 1500
Sponsors
Collaborators: University of Maryland, Baltimore, Virginia Commonwealth University, Medstar Health Research Institute, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov