MCE Molecular Imaging in Myocarditis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy for presence/absence of ICI Myocarditis
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years of age
- •At least two of the following manifestations of 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
- •Predisposing condition or therapy associated with heightened risk of acute myocarditis (i.e. SARS-CoV-2, Parvovirus, Immune checkpoint inhibitors)
排除标准
- •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.)
研究组 & 干预措施
Patients with suspected Myocarditis
Patients with any degree of suspicion for myocarditis based on symptoms, lab tests, ECG, or imaging tests.
干预措施: Myocardial contrast echocardiography molecular imaging for inflammation (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy for presence/absence of ICI Myocarditis
时间窗: 3 months
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).
Diagnostic accuracy for presence/absence of Myocarditis
时间窗: 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).
次要结局
- Response to therapy(3 month)
研究者
Jonathan Lindner, MD
Professor of Medicine
University of Virginia