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临床试验/NCT04437927
NCT04437927已完成不适用

Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose

Centre Hospitalier Princesse Grace1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2020年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Uptake in the heart scoring according to a visual scale

研究概览

简要总结

There is increasing evidence that [18F]-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT is useful in the identification and treatment of disease processes that involve cardiac inflammation and infection. Current applications include imaging intra-cardiac device and prosthetic valve infections, evaluating patients with known or suspected cardiac sarcoidosis or other inflammatory cardiomyopathies.

However, because normal myocardium can metabolize both glucose and free fatty acids (FFAs), physiological accumulation of FDG in the myocardium can interfere with the recognition of abnormal FDG uptake.

The use of a low-carbohydrate diet with a prolonged fast ≥ 12 h nutrition followed by a fast of at least four hours is the effective preparation recommended to suppress physiological myocardial FDG uptake.

However, the rate of suppression of physiological accumulation of FDG with this method in our center is only 50%.

详细描述

Methodology :

Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled, compared to a group with the last 30 patients referred for cardiac FDG PET in the nuclear medicine department of the Centre Hospitalier Princesse Grace.

Procedures :

Infusion of 100mL lipid emulsion for intravenous two hours before cardiac FDG PET/CT:

  • Infusion rate will be 20 mL/hour during the initial 10 minutes (3 mL Intralipid)
  • The dose will be then increased to 40 mL/hour for the next 10 minutes (6 mL Intralipid)
  • Finally, for the next 50 minutes the dose will be increased to 100 mL/hour (83mL Intralipid)

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with an FDG PET/CT prescribed to explore cardiac disease process

排除标准

  • renal insufficiency,
  • uncompensated diabetes mellitus,
  • pancreatitis,
  • liver insufficiency,
  • hypothyroidism
  • metabolic disorders
  • soy protein allergy

结局指标

主要结局

Uptake in the heart scoring according to a visual scale

时间窗: day 1

* Score of 0: complete myocardial suppression * Score of 1: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial interpretation but not cardiac valves. * Score of 2: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial and mitral or aortic valve interpretations. * Score of 3: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial and both mitral and aortic valves interpretations.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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