[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07538544":3,"trial-entities:NCT07538544":97,"trial-summary:NCT07538544":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":48,"minimum_age":49,"maximum_age":17,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":64,"locations":67,"central_contacts":82,"overall_officials":84,"references":88,"see_also_links":96},"NCT07538544","HSR 303588","MCE Molecular Imaging for Myocarditis","MCE Molecular Imaging in Myocarditis","NOT_YET_RECRUITING","2030-07-01","2026-08","2026-08-20","2026-09-15","University of Virginia","OTHER",true,"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).",null,[19],"Myocarditis Acute",[21,22,23],"Myocarditis","Myocardial contrast echocardiography","Molecular imaging","INTERVENTIONAL","DIAGNOSTIC",[27],"EARLY_PHASE1",{"count":29,"type":30},30,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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.",[37],"Patients with suspected Myocarditis",[39],{"measure":40,"description":41,"timeFrame":42},"Diagnostic accuracy for presence\u002Fabsence 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).","3 months",[44],{"measure":45,"description":46,"timeFrame":47},"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","ALL","18 Years",false,{"inclusion":52,"exclusion":55,"raw_text":63},[53,54],"Age ≥18 years of age","At least two of the following manifestations of myocarditis:",[56,57,58,59,60,61,62],"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.)","Inclusion Criteria:\n\n* Age ≥18 years of age\n* At least two of the following manifestations of myocarditis:\n\n  1. new or suspected new high-sensitivity troponin \\>3 times upper limit of normal\n  2. new or suspected new LV dysfunction with LVEF \\\u003C50% or any segmental wall motion abnormality in the absence of prior ischemic event\n  3. ECG changes consistent with myocarditis defined as either diffuse ST elevation or ST-T abnormalities that are documented to be new,\n  4. unexplained severe ventricular arrhythmias,\n  5. Cardiac MR evidence for myocarditis\n  6. Predisposing condition or therapy associated with heightened risk of acute myocarditis (i.e. SARS-CoV-2, Parvovirus, Immune checkpoint inhibitors)\n\nExclusion Criteria:\n\n* Inability to obtain consent\n* High pre-test likelihood for ACS based on ECG and history\n* Pregnancy or planned pregnancy\n* Lactation\n* Allergy to ultrasound contrast agents or eggs\n* Treatment with potent immunosuppressive therapy beyond corticosteroids\n* Conditions associated with inflammatory myopathy (SLE, giant cell myocarditis, sarcoidosis, etc.)",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":13,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":79},"Charlottesville","Virginia","22903","United States",[74],{"name":75,"role":76,"phone":77,"email":78},"Jonathan Lindner, MD","CONTACT","14342979442","jlindner@virginia.edu",{"lat":80,"lon":81},38.02931,-78.47668,[83],{"name":75,"role":76,"phone":77,"email":78},[85],{"name":86,"affiliation":13,"role":87},"Jonathan Lindner","PRINCIPAL_INVESTIGATOR",[89,93],{"pmid":90,"type":91,"citation":92},"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\u002Fj.jcmg.2015.11.031. Epub 2016 Jun 15.",{"pmid":94,"type":91,"citation":95},"34763776","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\u002Fj.jacc.2021.08.068.",[],{"nct_id":4,"conditions":98,"biomarkers":99},[21],[],{"nct_id":4,"found":15,"summary":101,"prompt_version":111},{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an interventional study, meaning participants will receive a specific diagnostic test. It aims to enroll 30 participants.","completed","MCE Molecular Imaging for ICI Myocarditis","This study is looking into a new way to diagnose a serious heart condition called immune checkpoint inhibitor (ICI) myocarditis. This condition can happen as a side effect of certain cancer medications (immune checkpoint inhibitors) that boost your body's immune response. Researchers are testing if a special type of heart ultrasound (echocardiography) using a contrast agent called Sonazoid can accurately find this heart inflammation. Sonazoid helps highlight areas of inflammation. The main goal is to see how accurate this imaging method is at detecting ICI myocarditis after 3 months. You may be able to join if you are 18 or older, have recently received ICI therapy, and show at least two signs of ICI myocarditis, such as elevated troponin levels. The current status of this study is unclear, and it plans to enroll 30 participants.","The primary endpoint for diagnostic accuracy is measured at 3 months.",135,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]