Effect of 18-FDG PET/CT Imaging on Clinical Decision Making During the Acute Phase of Infective Endocarditis: a Multicenter Prospective Impact Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Proportion of patients with a change in IE therapeutic plan
研究概览
简要总结
The purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. The study will evaluate whether this procedure can change the clinical decisions (treatments, valve surgery, patients' overall care) and modify the diagnosis of IE.
详细描述
Introduction:
Infective endocarditis (IE) is a rare disease, often difficult to diagnose with a high mortality rate. Extra-cardiac manifestations, which can occur in 30 to 80% of cases, impact the outcome of the disease. Identifying these manifestations may help confirm an uncertain diagnosis and optimize patients' management.
18-FDG PET/CT imaging, widely used for cancer staging, may also detect hyper-metabolic areas related to extracardiac infectious complications of IE. It provides the opportunity to detect all extracardiac IE infectious complications through a single examination. The impact of 18-FDG PET/CT imaging on the management of IE has yet to be completely evaluated.
Hypothesis:
18-FDG PET/CT implementation could result in both shortening of the initial diagnostic work-up of IE and therapeutic optimization.
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
- •Subjects aged ≥ 18 years
- •Presenting IE "Duke-Li definite - Duke-Li possible" or strong suspicion of IE "Duke-Li not definite or possible, with initiation of IE antibiotic therapy".
- •Transthoracic or transesophageal ultrasound performed.
- •A stable clinical condition which does not require immediate surgery or contraindicate patient mobilization
- •Absence of cardiac surgery for the current IE episode
- •Covered by the French health insurance system
- •Having given and signed the written study informed consent to the study.
排除标准
- •Patient having already had a 18-FDG PET/CT in the current episode
- •Contraindication to perform a 18-FDG PET/CT
- •Early prosthetic valve IE (cardiac surgery within last 2 months)
- •Inability to understand the information form
- •Pregnant or lactating woman.
- •Cardiac surgery between inclusion and 18-FDG PET/CT
- •Participation to any clinical trial including 18-FDG PET/CT
研究组 & 干预措施
18-FDG PET/CT scan
All patients will undergo a whole body PET/CT scan
干预措施: 18-FDG PET/CT scan (Procedure)
结局指标
主要结局
Proportion of patients with a change in IE therapeutic plan
时间窗: 7 days
at least one modification in antimicrobial or anticoagulant therapy (types, route, dose, number, duration, indication...) or any modification of surgery (type, timing, indications...)
次要结局
- Proportion of patients with Duke-Li classification modifications(6 months)
- Performances of 18-FDG PET/CT in detection of IE localization as compared to other usual procedures(6 months)
- 18-FDG PET/CT inter-reader reproducibility(6 months)
- 6-month mortality rate(6 months)
- Determinants of change in therapeutic plan as defined in primary outcome(6 months)