Actively Recruiting

Age: 21Years - 80Years
All Genders
ID01076660

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

Led by Johns Hopkins University · Updated on 2026-01-20

400

Participants Needed

2

Research Sites

104 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) is a major health challenge with a high number of cases each year and low survival rates. Implantable cardioverter defibrillators (ICDs) help prevent SCD in patients with poor heart function, specifically those with left ventricular ejection fraction (LVEF) of 35% or less. However, current selection methods mean only a small portion of patients truly benefit from ICDs, creating a need for better ways to predict who is at risk. This research focuses on whether detailed structural features of the heart, beyond overall heart function, can better predict SCD risk using cardiac magnetic resonance imaging (CMR). The study uses CMR with late gadolinium enhancement to measure detailed heart structure, including function, size, mass, shape, and scar tissue in patients with reduced LVEF who are being considered for ICDs to prevent SCD. It aims to see if these structural measurements combined with other clinical factors can more accurately identify patients at higher risk of SCD compared to current methods. This prospective study involves a large group of patients to assess the added value of heart structure assessment in predicting SCD risk. Participants will be followed for up to five years with evaluations every six months to monitor outcomes related to SCD and other cardiac events. Researchers will review composite outcomes of sudden cardiac death and cardiac health over this period. The study involves clinical assessments and imaging tests to collect data and track participants' health status, aiming to improve future risk stratification for SCD prevention and better target ICD therapy.

CONDITIONS

Brief 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) of 35% or less
  • Referred clinically for implantable cardioverter defibrillator (ICD) insertion for primary prevention (no prior sustained ventricular arrhythmias)
  • Between 21 and 80 years old
  • Permission from the patient's clinical attending physician
Not Eligible

You will not qualify if you...

  • Refusal or inability to give consent
  • Contraindications to MRI such as implanted metallic objects (e.g., pacemakers, cerebral clips, metallic projectiles)
  • Under 21 years old (minors)
  • Pregnant women
  • New York Heart Association (NYHA) Class IV heart failure
  • Chronic renal insufficiency with creatinine clearance less than 60 ml/min or any acute renal insufficiency
  • Claustrophobia
  • Prior adverse reaction to gadolinium-based contrast

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single assessment

Participants undergo detailed cardiac magnetic resonance imaging (CMR) to assess left ventricular structure and function.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for sudden cardiac death and cardiac outcomes over time to evaluate risk based on LV structural indices.

Visits every 6 months for up to 5 years

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

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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Published Research Related To This Trial

Infarct tissue heterogeneity by magnetic resonance imaging identifies enhanced cardiac arrhythmia susceptibility in patients with left ventricular dysfunction.

André Schmidt, Clerio F Azevedo, Alan Cheng...

https://pubmed.ncbi.nlm.nih.gov/17389270

Enhanced infarct border zone function and altered mechanical activation predict inducibility of monomorphic ventricular tachycardia in patients with ischemic cardiomyopathy.

Verônica Rolim S Fernandes, Katherine C Wu, Boaz D Rosen...

https://pubmed.ncbi.nlm.nih.gov/17911537

Late gadolinium enhancement by cardiovascular magnetic resonance heralds an adverse prognosis in nonischemic cardiomyopathy.

Katherine C Wu, Robert G Weiss, David R Thiemann...

https://pubmed.ncbi.nlm.nih.gov/18565399

Tissue sodium concentration in myocardial infarction in humans: a quantitative 23Na MR imaging study.

Ronald Ouwerkerk, Paul A Bottomley, Meiyappan Solaiyappan...

https://pubmed.ncbi.nlm.nih.gov/18566171

Reduced myocardial creatine kinase flux in human myocardial infarction: an in vivo phosphorus magnetic resonance spectroscopy study.

Paul A Bottomley, Katherine C Wu, Gary Gerstenblith...

https://pubmed.ncbi.nlm.nih.gov/19332463

ECG quantification of myocardial scar in cardiomyopathy patients with or without conduction defects: correlation with cardiac magnetic resonance and arrhythmogenesis.

David G Strauss, Ronald H Selvester, João A C Lima...

https://pubmed.ncbi.nlm.nih.gov/19808427

Arrhythmia risk stratification of patients after myocardial infarction using personalized heart models.

Hermenegild J Arevalo, Fijoy Vadakkumpadan, Eliseo Guallar...

https://pubmed.ncbi.nlm.nih.gov/27164184

Associations between scar characteristics by cardiac magnetic resonance and changes in left ventricular ejection fraction in primary prevention defibrillator recipients.

Yiyi Zhang, Eliseo Guallar, Robert G Weiss...

https://pubmed.ncbi.nlm.nih.gov/27108939