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PET scans may outshine ejection fraction in predicting sudden cardiac death

NCT ID NCT03493516

Knowledge-focused Sponsor: State University of New York at Buffalo Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a special PET scan can help doctors better predict sudden cardiac arrest in people with heart failure and blocked arteries. About 300 participants who already have a defibrillator will be followed to see if heart nerve damage, heart size, or blood markers improve risk prediction. The goal is to improve how we identify high-risk patients beyond the current standard of measuring heart pumping strength.

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

About 302 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

The study population comprises adult patients of either sex with ischemic cardiomyopathy who have an ejection fraction ≤ 35% and New York Heart Association Class II or III CHF or an ejection fraction ≤ 30% and Class I CHF who are candidates to place an ICD for the primary prevention of SCA. Subjects already having a primary prevention ICD are eligible if they have not yet received an appropriate ICD shock for ventricular arrhythmias.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Coronary artery disease (by cardiac catheterization or definite myocardial infarction) * ICD implantation for the primary prevention of SCA * Primary prevention patients with a Biventricular ICD * Eligible immediately when this is placed to prevent dysynchrony related to intermittent RV pacing and the native QRS duration is ≤ 130 msec in the absence of pacing. * Eligible 6 months after implantation when the native QRS duration prior to implant is \>130 msec or there is persistent RV pacing. * Optimal medical therapy for heart failure. Exclusion Criteria: * Plans for coronary revascularization (due to the independent impact on SCA) * Contraindication for PET (i.e. claustrophobia, pregnancy, physical limitation) * Tricyclic antidepressant use (inhibits norepinephrine and LMI1195 uptake) * Comorbidities limiting life expectancy \<2yr. * Age \<18 years or inability to provide informed consent * Primary prevention ICD/BiV recipients who have received an appropriate ICD shock prior to enrollment

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Conditions

The condition(s) this trial relates to.

cardiomyopathy congestive heart failure coronary artery disorder Death, Sudden Death, Sudden, Cardiac heart failure sudden cardiac arrest ventricular fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congestive heart failure Ischemic cardiomyopathy Sudden cardiac arrest

Contacts and locations

Locations

  • University at Buffalo Clinical and Translational Research Center

    Buffalo, New York, 14214, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.