Prospective Assessment of the Clinical Utility of Cardiovascular Magnetic Resonance in Patients With Suspected Acute Myocarditis - A Pilot Study for Establishing an International Registry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 试验地点
- 1
研究概览
简要总结
Myocarditis is an inflammatory heart disease primarily of viral origin that can lead to heart failure and death. Despite an unfavorable long-term outcome and mortality rate as high as 50%, classification, diagnosis, and treatment of myocarditis remains controversial. The gold standard for clinical diagnosis is direct sampling of the heart muscle, which often misses the infected area and thus reliability of the test is questionable. While the cause and clinical presentation of myocarditis are often unclear, inflammation of the heart muscle can be clearly imaged by Cardiovascular Magnetic Resonance Imaging (CMR).
Due to recent international consensus on CMR protocol for myocarditis and the unique ability of CMR to visualize cardiac structure, function, and characterize tissue, CMR has become the primary tool for clinical assessment. This study aims to test the accuracy of CMR in the diagnosis of myocarditis and to validate whether CMR acquired in an early stage of myocarditis can provide incremental prognostic information. In order to effectively gather relevant clinical data, an online, multi-centre international registry will be established across twenty different medical institutions.
Hypotheses:
- CMR accurately detects active myocardial inflammation in patients with myocarditis
- CMR acquired in an early clinical stage of myocarditis provides incremental prognostic information superior to standard clinical diagnostic tools.
详细描述
Study Rationale Because of its unique combination of morphological and functional imaging with tissue characterization, cardiovascular magnetic resonance (CMR) has become the non-invasive diagnostic tool of choice for assessing myocarditis. Recently, standard diagnostic CMR criteria for myocarditis have been proposed ("Lake Louise Criteria"), based on signal intensity patterns in T2-weighted images and T1-weighted images before and after contrast administration 3.
There is however a lack of prognostic data using these criteria. Furthermore, the clinical utility of these criteria in a real-life scenario is not well understood.
The aim of the study is to evaluate the diagnostic CMR criteria for the prediction of functional outcome and quality of life in patients with myocarditis.
Background: Myocarditis Myocardial inflammation, most often caused by myocardial involvement in systemic viral illness, although typically of benign outcome, may result in persisting myocardial damage. Clinical outcomes include heart failure and death. Chronic myocarditis can progress to dilated cardiomyopathy which result in dilation and decompensation of one or both ventricles resulting in heart failure, with the need for cardiac transplantation.
Diagnostic approach to myocarditis The diagnosis of myocarditis is generally considered after exclusion of other causes of acute heart disease and established by a combination of history, physical examination with non-invasive or invasive tests.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 2 positive CMR criteria for myocarditis as acquired by a CMR study within less than 10 days of the onset of symptoms suggestive of myocarditis (fever, symptoms of systemic viral disease)
- •Evidence for cardiac involvement (elevated troponin, arrhythmia and/or ECG changes)
排除标准
- •Contraindication to CMR, such as implanted metal object, reaction to gadolinium, or severe claustrophobia
- •Acute or severe renal insufficiency (rapid increase of creatinine or creatinine clearance of ≤ 30ml/min)