Heart scan features that may predict sudden cardiac death in cardiomyopathy
Studies heart structure on magnetic resonance imaging in people with ischemic or nonischemic cardiomyopathy.
Key facts
- Who runs it
- Johns Hopkins University
- Where
- Baltimore and Newark, United StatesSee the 2 sites
- Trial code
- Registry title
- Left Ventricular Structural Predictors of Sudden Cardiac Death
- Status
- Recruiting
- People taking part
- 400 people, planned
- Started
- Oct 2003
- Expected to end
- Jun 2030
- Type of study
- Observational
- Record updated
- 20 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with weak heart pumping (LVEF≤35%) who are sent for an ICD (a device that shocks the heart back into rhythm) to prevent sudden cardiac death. The heart's structure is studied with MRI scans.
- Age
- 21 to 80 years
- Sex
- All sexes
- Disease stage
- Ischemic or nonischemic cardiomyopathy with LVEF≤35%. People with NYHA Class IV heart failure cannot join.
- Earlier treatment
- Must be referred for ICD insertion to prevent a first event. No prior history of sustained ventricular arrhythmias (long-lasting dangerous fast heart rhythms).
- Biomarker or test result
- LVEF≤35% (share of blood pumped out of the heart with each beat)
Main reasons for not taking part
- Cannot have an MRI, for example a pacemaker, brain clips or metal pieces in the body
- Pregnant women
- NYHA Class IV heart failure
- Chronic kidney weakness with creatinine clearance<60 ml/min, or sudden kidney failure of any severity
- Fear of closed spaces, or a past bad reaction to gadolinium-based contrast dye
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior adverse reaction to gadolinium-based contrast
- Individuals with contraindications to MRI (i.e. implanted metallic objects such as pre-existing cardiac pacemakers, cerebral clips or indwelling metallic projectiles)
- NYHA Class IV heart failure
- Chronic renal insufficiency with creatinine clearance<60 ml/min; acute renal insufficiency of any severity
- Patients who refuse or are unable to give consent
- Minors
- Pregnant women
- Claustrophobia
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 80 years old?
Where in United States
- Johns Hopkins Medical InstitutionsBaltimore, United StatesContact: Katherine Wu, MD (principal investigator)Taking people
- Christiana Care Health ServicesNewark, United StatesContact: Katherine Wu, MDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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]
- Plain-language title
- Heart scan features that may predict sudden cardiac death in cardiomyopathyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT01076660, who can take part
- Record updated
- 20 January 2026