Myocarditis Acute
Conditions
Keywords
Myocarditis, Myocardial contrast echocardiography, Molecular imaging
Brief summary
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).
Interventions
DIAGNOSTIC_TESTMyocardial contrast echocardiography molecular imaging for inflammation
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.
Sponsors
University of Virginia
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years of age * At least two of the following manifestations of myocarditis: 1. new or suspected new high-sensitivity troponin \>3 times upper limit of normal 2. new or suspected new LV dysfunction with LVEF \<50% or any segmental wall motion abnormality in the absence of prior ischemic event 3. ECG changes consistent with myocarditis defined as either diffuse ST elevation or ST-T abnormalities that are documented to be new, 4. unexplained severe ventricular arrhythmias, 5. Cardiac MR evidence for myocarditis 6. Predisposing condition or therapy associated with heightened risk of acute myocarditis (i.e. SARS-CoV-2, Parvovirus, Immune checkpoint inhibitors)
Exclusion criteria
* 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy for presence/absence of Myocarditis | 3 months | The ability of of MCE molecular imaging with Sonazoid to diagnose myocarditis will be determined by comparing to a gold standard (either cardiac MRI or myocardial biopsy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response to therapy | 3 month | The ability of MCE molecular imaging to detect a reduction in inflammation as a response to immune suppressive therapy will be evaluated by repeat MCE molecular imaging 14 days after starting immune suppressive therapy, and evaluation of cardiac function at 3 months. |
Countries
United States
Contacts
CONTACTJonathan Lindner, MD
PRINCIPAL_INVESTIGATORJonathan Lindner
University of Virginia
Outcome results
None listed