Multiparametric Tissue Characterisation of Myocardial Inflammation in Autoimmune Rheumatic Diseases (AIRD) Using Cardiovascular Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of novel versus conventional sequences
研究概览
简要总结
Myocarditis is an important clinical problem which can can occur as a result of viral infections and autoimmune rheumatic diseases. Cardiac MRI is an important non-invasive means of making a diagnosis. However, current MRI techniques have significant limitations. Firstly, in order to create high-quality pictures, patients are required to hold their breath several times for multiple lengths of time. They often struggle with this due to underlying heart/lung problems. This can adversely affect the overall quality and image interpretation. Secondly, current techniques create 2D images that are potentially underestimating the presence and severity of any tissue inflammation/ injury. This may result in inappropriate treatment, particularly for patients with underlying autoimmune systemic disease who require immunosuppression.
Diagnosis by MRI rests on detecting tissue injury through T2 and T1-weighted sequences which detect tissue inflammation and tissue injury. The purpose of this study is to evaluate the diagnostic accuracy of novel 3D free-breathing sequences for T2-weighted and fibrosis/ LGE imaging.
Patients with suspected isolated myocarditis (viral/idiopathic) or myocarditis as part of an autoimmune systemic disease will be recruited to ensure that the novel techniques are tested in a broad spectrum of patients with inflammatory heart muscle disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients referred for CMR for clinically suspected myocarditis either idiopathic or in the context of autoimmune rheumatic disease.
- •Patients who are able to give informed consent.
排除标准
- •Patients in atrial fibrillation.
- •Patients who are unable to give informed consent.
- •Patients whose physical or mental condition indicates that the additional time in the CMR scanner should be minimised.
- •Patients who cannot have CMR due to either contraindications to CMR (e.g., non-conditional intracardiac devices) or contraindications to contrast (e.g., history of allergy to gadolinium).
结局指标
主要结局
Diagnostic accuracy of novel versus conventional sequences
时间窗: 2 weeks
The CMR diagnosis of myocarditis will be made according to the revised (2018) Lake Louise criteria which mandate an increase in T2 (signal intensity in arbitrary units or absolute values in ms) and a T1-based marker (either absolute T1 in ms or LGE). T2-times and LGE from the novel 3D sequences will be combined as per revised Lake Louise criteria recommendations to make a diagnosis and compared with the conventional clinical sequences. A clinical diagnosis of cardiovascular inflammation will be made by an expert consensus adjudication panel initially based on evaluation of the patient's history and examination findings; ECG; the results of laboratory testing; and ancillary imaging findings. To avoid incorporation bias, the initial assessment will be blinded to tissue characterisation findings, and the classification will be compared between new and old methods using ROC analysis and the DeLong test.
次要结局
- Acquisition time for both conventional and novel sequences versus conventional sequences(2 weeks)
- Proportion of diagnostic images with novel versus conventional sequences(2 weeks)
- Quantitative accuracy and precision of novel 3D sequences compared with conventional sequences(2 weeks)