Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- the diagnosis of prosthetic valve infective endocarditis
研究概览
简要总结
The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases, initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a decreased diagnostic accuracy for the modified Duke criteria.
Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.
Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou European Hospital, Paris), the investigators plan to include consecutive patients suspected of having PVE. All of the patients will be subjected to clinical, microbiological, and echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data analysis will be based on visual interpretation and quantitative measurement of FDG uptake (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological modified Duke criteria determined during a 3-month follow-up (gold standard).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •unexplained persistent or recurrent fever >38°C;
- •and/or unexplained increased serum C-reactive protein (CRP) level >10 mg/L; and/or positive blood cultures, independent of the echocardiographic analysis results;
- •and/or positive serological testing for Coxiella burnetii, Bartonella spp., Mycoplasma pneumoniae, Legionella pneumophila, Aspergillus spp., or Tropheryma whipplei;
- •and/or a mass or a new partial prosthetic valve dehiscence observed using echocardiography.
排除标准
- •pregnancy,
- •an inability to lie flat,
- •a need for urgent cardiac surgery,
- •hemodynamic instability,
- •cardiac surgery <1 month ago,
- •and a blood glucose level >1.8 g/L. Patients with a poor PET/CT image quality
结局指标
主要结局
the diagnosis of prosthetic valve infective endocarditis
时间窗: 39months
18F-fluorodeoxyglucose positron emission tomography
次要结局
- the prognostic value of the technique (death/valve surgery)(39 MONTHS)
- the rate of detection of embolic events,(39 MONTHS)
- the comparison of the sensitivity of PET/CT with that of echocardiography,(39 MONTHS)
- the reproducibility of the technique,(39 months)