Evolution of Positron Emission Computed Tomography (PET) Fixation With Fluorodeoxyglucose (FDG) at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Presence of pathological uptake on the prosthetic valve on FDG-PET
研究概览
简要总结
In patients with prosthetic valve endocarditis (PVE) and pathological valvular FDG uptake on the initial FDG-PET and not referred to valve replacement at the acute phase, the study will assess whether FDG-PET is able to identify those at increased risk of PVE relapse.
详细描述
In patients medically treated for prosthetic valve infection (PVE), identification of persistent infection or of cure could be very useful to 1/ patients referral to high-risk surgery, 2/ initiation of suppressive antibiotic therapy, or 3/ simplify the follow-up in other patients. The hypothesis is that FDG-PET could thus identify patients at increased risk of recurrence in case of persistent pathological uptake In patients with prosthetic endocarditis and pathological valvular FDG uptake on the initial FDG-PET and not referred to valve replacement at the acute phase, the main objective is to estimate the proportion of those still showing pathological valvular FDG uptake after curative antibiotic treatment. The secondary objectives are 1/ to quantitatively compare the valvular FDG-PET uptake for each individual before and after treatment; 2/ to determine the proportion of those in whom extracardiac foci persist at the end of treatment ; 3/ to evaluate the association between valvular FDG uptake on PET at the end of treatment and PVE relapse at 6 months; 4/ to evaluate the diagnostic performance of an automatic analysis by artificial intelligence of FDG uptake before and after treatment to predict PVE relapse at 6 months.
This is a single-center prospective cohort study. The population is composed of 50 adults with definite PVE according to the ESC 2015 classification, not operated in the acute phase and with pathological FDG-PET at the beginning of curative antibiotic treatment.
A change in practices regarding the duration of antibiotic therapy and the use of valve replacement surgery and its potential complications would benefit patients and reduce the overall cost related to valve prosthesis infection to the healthcare system."
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •"Inclusion criteria:
- •Patient aged 18 or over;
- •Have a prosthetic valve implanted surgically or by catheter for at least 3 months;
- •Presenting a definite IE on a prosthetic valve (ESC definition in force);
- •Having benefited from an FDG-PET examination for diagnostic purposes as part of the treatment revealing pathological hyperuptake at the level of the prosthetic valve AND carried out <15 days after the start of antibiotic therapy for infective endocarditis;
- •Absence of cardiac surgical intervention performed for the current episode of AE or planned before the end-of-treatment FDG-PET
排除标准
- •Patient under legal protection, guardianship or curators;
- •Pregnancy, breastfeeding;
- •Patient not affiliated to a health insurance scheme or not a beneficiary of a social security scheme;
- •Simultaneous participation in a study on FDG-PET;
- •Absence of informed consent signed by the patient."
研究组 & 干预措施
Definite prosthetic valve endocarditis
adult patients with a valvular prosthesis presenting a definite infective endocarditis (IE) according to the ESC classification in force, not operated on in the acute phase (before the PET scan at the end of treatment) and presenting a pathological FDG uptake on the prosthetic valve at the start of curative antibiotic treatment.
干预措施: FDG-PET at the end of treatment for IE (Radiation)
结局指标
主要结局
Presence of pathological uptake on the prosthetic valve on FDG-PET
时间窗: at inclusion
Presence of pathological uptake on the prosthetic valve on FDG-PET performed after the recommended duration of curative antibiotic treatment
次要结局
- Evolution of the FDG uptake intensity on the prosthetic valve by FDG-PET(at inclusion)
- Therapeutic impact of end-of-treatment PET-FDG measured by stopping or continuing antibiotic treatment(6 month)
- Diagnostic performance of AI to predict relapse of endocarditis defined by the same location and the same microorganism within 6 months(6 month)
- Evolution of the intensity of extracardiac uptake on the FDG-PET at the end of curative antibiotic treatment in patients presenting with pathological extracardiac uptake on the initial FDG-PET(at inclusion)
- Presence of the intensity of extracardiac uptake on the FDG-PET at the end of curative antibiotic treatment in patients presenting with pathological extracardiac uptake on the initial FDG-PET(at inclusion)
- Relapse of endocarditis defined by the same location and the same microorganism within 6 months(6 month)