Left Ventricular Structural Predictors of Sudden Cardiac Death [Substudy of: Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death, See Also NCT000181233]

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with poor heart function. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of reduced heart function, specifically left ventricular ejection fraction (LVEF)≤35%, as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (\<25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification. This project examines the hypothesis that structural abnormalities of the heart itself, above and beyond global LV dysfunction, are important predictors of SCD risk since they indicate the presence of the abnormal tissue substrate required for the abnormal electrical circuits and heart rhythms that actually lead to SCD. Information about the heart's structure will be obtained from cardiac magnetic resonance imaging and used in combination with a number of other clinical risk factors to see if certain characteristics can better predict patients at risk for SCD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• LVEF≤35%, referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)

• Between the ages of 21 and 80 years old

• Permission of the patient's clinical attending physician

Locations
United States
Delaware
Christiana Care Health Services
ACTIVE_NOT_RECRUITING
Newark
Maryland
Johns Hopkins Medical Institutions
RECRUITING
Baltimore
Contact Information
Primary
Katherine Wu, MD
kwu@jhmi.edu
410-502-7283
Time Frame
Start Date: 2003-10
Estimated Completion Date: 2030-06
Participants
Target number of participants: 400
Related Therapeutic Areas
Sponsors
Collaborators: Christiana Care Health Services, Donald W. Reynolds Foundation
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov