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临床试验/NCT03777839
NCT03777839已完成不适用

Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography Imaging in Myocarditis

Montreal Heart Institute1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis

研究概览

简要总结

This study evaluates the diagnostic performance of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) with rest perfusion imaging for the diagnosis of myocarditis. Patients with clinical suspicion of myocarditis will be recruited and undergo a rest myocardial perfusion scan and a FDG PET/CT scan following a myocardial suppression protocol.

详细描述

Myocarditis is characterized by myocardial inflammation, which can lead to fibrosis and heart failure.

FDG PET/CT, with appropriate suppression protocol including high-fat-low-carbohydrate diet, fasting, and IV heparin, can be use to detect myocardial inflammation. It is frequently used for the diagnosis of inflammation in cardiac sarcoidosis. After the initial inflammatory phase, inflammation resolves and fibrosis can seen. Resting perfusion imaging will allow identification of fibrosis. The combination of FDG PET/CT and rest perfusion imaging could allow detection of the various phases of myocarditis; inflammation and fibrosis.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Clinical suspicion of myocarditis due to findings such as:
  • Symptoms and signs of myocarditis such as dyspnea, orthopnea, palpitation, and chest pain, without other identifiable cause
  • New onset of cardiovascular symptoms with recent history of viral disease or previous myocarditis
  • Unexplained new onset of left ventricular dysfunction
  • Unexplained elevated troponin
  • Magnetic resonance imaging findings suggestive of myocarditis, such as late gadolinium enhancement and edema
  • Biopsy findings compatible with myocarditis
  • Women of childbearing potential must have a negative urine or blood pregnancy test
  • Capable of giving informed consent and the consent must be obtained prior to any study related procedures
  • Subject's with body mass index inferior or equal to 45 kg/m2

排除标准

  • Female subject who is pregnant or breastfeeding and unwilling to stop for 24h
  • Claustrophobia or inability to lie still in a supine position for imaging purposes
  • Unwillingness or inability to provide informed consent

结局指标

主要结局

Sensitivity of FDG PET/CT imaging with rest perfusion imaging to detect myocarditis

时间窗: 1 year

Sensitivity of FDG-PET/CT with rest perfusion imaging

次要结局

  • Left ventricular ejection fraction(1 year)
  • Specificity and accuracy of FDG-PET/CT with rest perfusion imaging to detect myocarditis(1 year)

研究者

发起方
Montreal Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthieu Pelletier-Galarneau, MD MSc

Adjunct Professor of Clinic

Montreal Heart Institute

研究点 (1)

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PET-FDG in Myocarditis | 临床试验