What this study is
Inflammation of the heart (myocarditis) is a serious condition that can cause heart failure, abnormal heart rhythms, cardiac arrest, and death. Rapid diagnosis of this condition is key to reversing it. The purpose of this study is to determine whether myocarditis such as that which occurs with viral illness, autoimmune conditions, or certain therapies (i.e. immune checkpoint inhibitors) can be diagnosed using a new form of ultrasound imaging of the heart (echocardiography) that uses a contrast agent that is targeted to inflammation (Sonazoid).
What's being tested
- Myocardial contrast echocardiography molecular imaging for inflammation
Intervention · DIAGNOSTIC TEST
Myocardial contrast echocardiography (ultrasound of the heart) using an ultrasound contrast agent (Sonazoid, GE Healthcare) that contains phosphatidylserine, thereby targeting it to leukocytes and activated endothelium.
Study details
- Official title
- MCE Molecular Imaging in Myocarditis
- Sponsor
- University of Virginia
- Conditions
- Myocarditis Acute
- Enrolling
- 30 people
- Starts
- 2026-09-15
- Est. completion
- 2030-07-01
- Design
- Open-label, non-randomized, single group, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age ≥18 years of age
- At least two of the following manifestations of myocarditis:; new or suspected new high-sensitivity troponin >3 times upper limit of normal; new or suspected new LV dysfunction with LVEF <50% or any segmental wall motion abnormality in the absence of prior ischemic event; ECG changes consistent with myocarditis defined as either diffuse ST elevation or ST-T abnormalities that are documented to be new,; unexplained severe ventricular arrhythmias,; Cardiac MR evidence for myocarditis; Predisposing condition or therapy associated with heightened risk of acute myocarditis (i.e. SARS-CoV-2, Parvovirus, Immune checkpoint inhibitors)
You can't join if
- Inability to obtain consent
- High pre-test likelihood for ACS based on ECG and history
- Pregnancy or planned pregnancy
- Lactation
- Allergy to ultrasound contrast agents or eggs
- Treatment with potent immunosuppressive therapy beyond corticosteroids
- Conditions associated with inflammatory myopathy (SLE, giant cell myocarditis, sarcoidosis, etc.)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Virginia
Charlottesville, Virginia, United States
- Jonathan Lindner, MD · Contact14342979442jlindner@virginia.edu
Study team
Sponsor
University of Virginia
Study ID HSR 303588
Principal investigator
Jonathan Lindner
University of Virginia
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.