MCE Molecular Imaging for Myocarditis
ConditionMyocarditis Acute
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years of age
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,
Disqualifiers
Inability to obtain consent
High pre-test likelihood for ACS based on ECG and history
Pregnancy or planned pregnancy
Lactation
Trial design
Design model
Single group
Treatments tested in this trial
Myocardial contrast echocardiography molecular imaging for inflammation
Diagnostic testMyocardial 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients with suspected MyocarditisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy for presence/absence of Myocarditis
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).
Time frame
3 monthsSecondary outcomes
1
Response to therapy
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.
Time frame
3 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Virginia
Lead sponsor
GE Healthcare
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: