Myocarditis and the Role of Advanced Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Accuracy, sensitivity and specificity of magnetic resonance imaging sequences
研究概览
简要总结
The purpose of this study is the assess the diagnostic performance of magnetic resonance imaging in patients with suspected myocarditis by applying different imaging sequences at different MR scanners
详细描述
In patients with clinical suspicion of myocarditis biventricular endomyocardial biopsy is performed for definite diagnosis. In addition, patients undergo magnetic resonance imaging at 1.5 Tesla and 3.0 Tesla within 24 hours. The imaging protocol of both scan include assessment of myocardial edema respectively edema ratio; myocardial hyperemia respectively global relative enhancement (gRE); myocardial fibrosis/necrosis respectively myocardial LE and T1 and T2 mapping sentences. Diagnostic performance of different imaging protocols as compared to the findings of endomyocardial biopsies is calculated.
The protocol also includes a follow-up MR can at 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms such as:
- •Dyspnea or Orthopnea or
- •Palpitations or
- •Exercise intolerance or
- •Evidence of myocardial involvement:
- •ventricular dysfunction on echocardiography or
- •new or persistent ECG changes
- •elevated Troponin T History of viral infection
排除标准
- •Contraindication for magnetic resonance imaging
- •Impaired renal function: glomerular filtration rate ≤ 30 ml/min/m2
- •Patients presenting with pregnancy
- •Patients without informed consent
- •Participation in another trial.
结局指标
主要结局
Accuracy, sensitivity and specificity of magnetic resonance imaging sequences
时间窗: baseline
The diagnostic accuracy of individual and a combination of MR imaging sequences (late enhancement images, assessment of global edema, relative enhancement and T1 and T2 mapping sequences) will be determined by comparison to endomyocardial biopsies, which serve as diagnostic gold-standard
次要结局
- Diagnostic performance of biventricular endomyocardial biopsies(baseline)
研究者
Philipp Lurz
Clinical Investigator, Professor, Managing Senior Physician
Heart Center Leipzig - University Hospital