MCE Molecular Imaging for ICI Myocarditis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Myocardial contrast echocardiography molecular imaging for inflammation.
- Who it may be relevant to
- Registry conditions: Immune Checkpoint Inhibitor Myocarditis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MCE Molecular Imaging in ICI Myocarditis
Overview
Inflammation of the heart (myocarditis) is a serious condition that can cause heart failure, abnormal heart rhythms, cardiac arrest, and death. A new class of medications used for cancer called immune checkpoint inhibitors (ICI) work by increasing the body's inflammmation response, but can have a side effect of causing inflammation of the heart (ICI myocarditis). Rapid diagnosis of this condition is key to reversing it. The purpose of this study is to determine whether ICI myocarditis 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 test Myocardial 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.
Primary outcome measures
- Diagnostic accuracy for presence/absence of ICI Myocarditis [Time frame: 3 months]
Secondary outcome measures (1)
- Response to therapy [Time frame: 3 month]
Eligibility criteria
Inclusion criteria
- Age ≥18 years of age
- Treatment with single or combination ICI therapy targeted to CTLA-4, PD-1, or PD-L1 with an ICI within the past week
- At least two of the following manifestations of ICI 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
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Virginia — Charlottesville
Publications
- Mott B, Packwood W, Xie A, Belcik JT, Taylor RP, Zhao Y, Davidson BP, Lindner JR. Echocardiographic Ischemic Memory Imaging Through Complement-Mediated Vascular Adhesion of Phosphatidylserine-Containing Microbubbles. JACC Cardiovasc Imaging. 2016 Aug;9(8):937-46. doi: 10.1016/j.jcmg.2015.11.031. Epub 2016 Jun 15. PMID 27318722
- Davidson BP, Hodovan J, Layoun ME, Golwala H, Zahr F, Lindner JR. Echocardiographic Ischemic Memory Molecular Imaging for Point-of-Care Detection of Myocardial Ischemia. J Am Coll Cardiol. 2021 Nov 16;78(20):1990-2000. doi: 10.1016/j.jacc.2021.08.068. PMID 34763776
Identifiers
NCT: NCT07538544 · HSR 303588