Actively Recruiting

Age: 21Years - 80Years
All Genders
NCT01076660

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

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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