Actively Recruiting
Left Ventricular Structural Predictors of Sudden Cardiac Death
Led by Johns Hopkins University · Updated on 2026-01-20
400
Participants Needed
2
Research Sites
1391 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
D
Donald W. Reynolds Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Left Ventricular Structural Predictors of Sudden Cardiac Death
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Left ventricular ejection fraction (LVEF) 35% or less
- Clinically referred for primary prevention implantable cardioverter defibrillator insertion
- Between 21 and 80 years old
- Approval from the patient's clinical attending physician
You will not qualify if you...
- Unable or unwilling to give consent
- Contraindications to MRI, including implanted metallic objects such as pacemakers or cerebral clips
- Minors
- Pregnant women
- New York Heart Association Class IV heart failure
- Chronic renal insufficiency with creatinine clearance less than 60 ml/min or acute renal insufficiency
- Claustrophobia
- Prior adverse reaction to gadolinium-based contrast
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Christiana Care Health Services
Newark, Delaware, United States, 19718
Active, Not Recruiting
2
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
K
Katherine Wu, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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