Heart MRI may spot who really needs a lifesaving shock device
NCT ID NCT01076660
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is looking at 400 people with weak hearts who are getting an implantable defibrillator (ICD) to prevent sudden cardiac death. Researchers want to see if detailed heart MRI scans can find structural problems that better predict who will actually have a dangerous heart rhythm. The goal is to improve how doctors decide who needs an ICD, avoiding unnecessary implants and their risks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better ways to identify who truly needs an implantable defibrillator, saving lives and avoiding unnecessary procedures.
- What could go wrong
- This is an observational study, not a treatment trial. It may not find a clear link, and results may not change practice for years.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Oct 2003
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with LV ejection fraction (LVEF) ≤35% of ischemic or nonischemic etiology (as measured by a clinical echocardiogram, ventriculogram, or radionuclide study) referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)
- Ages
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21 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * Patients who refuse or are unable to give consent. * Individuals with contraindications to MRI (i.e. implanted metallic objects such as pre-existing cardiac pacemakers, cerebral clips or indwelling metallic projectiles) * Minors. * Pregnant women. * NYHA Class IV heart failure. * Chronic renal insufficiency with creatinine clearance\<60 ml/min; acute renal insufficiency of any severity * Claustrophobia * Prior adverse reaction to gadolinium-based contrast
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Christiana Care Health Services
ACTIVE_NOT_RECRUITINGNewark, Delaware, 19718, United States
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Johns Hopkins Medical Institutions
RECRUITINGBaltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Mapping the Heart's hidden short circuits: a new ablation strategy for dangerous rhythms
- A blood test that foresees heart rhythms?
- New research could help heart failure patients get safer surgery
- Heart scan may predict who benefits from surgery
- MRI scans could help decide who needs a heart defibrillator
- Heart CT scans may spot hidden fat and scar linked to dangerous rhythms