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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with suspected ICI Myocarditis | Experimental | Patients with any degree of suspicion for ICI myocarditis based on symptoms, lab tests, ECG, or imaging tests. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myocardial contrast echocardiography molecular imaging for inflammation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy for presence/absence of ICI Myocarditis | The ability of of MCE molecular imaging with Sonazoid to diagnose ICI myocarditis will be determined by comparing to a gold standard (either cardiac MRI or myocardial biopsy). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 month |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Lindner, MD | Contact | 14342979442 | jlindner@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Lindner | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27318722 | Background | 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. | |
| 34763776 | Background |
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De-identified raw data will be provided upon request as outlined by the Data Sharing Plan developed in the course of NIH application.
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| ID | Term |
|---|---|
| D009205 | Myocarditis |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |