Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves
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University Hospital, Bordeaux
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信息的提供 (责任方):
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | April 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Sensitivity of the 18F-FDG PET-CT in the diagnosis of infectious endocarditis[ Time Frame: 3 month ] The reference test in this study will be a "definite diagnosis" of infectious endocarditis according to the ESC 2015 modified criteria at three months of follow-up, evaluated by a multidisciplinary committee in infectious endocarditis. This evaluation will be done blind to the results of the PET-CT of the study. The index test 18F-FDG PET-CT will have been performed at the initial phase of patient management. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves | ||
| 正式标题 ICMJE | Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves | ||
| 简要概况 | The diagnosis of infectious endocarditis is not always easy and is based on several clinical and imaging arguments. Positron Emission Tomography - Computed Tomography (PET-CT) has been validated for endocarditis on prosthetic valves but few studies concern the native valves. The purpose of the study is to estimate the diagnostic sensitivity of [18F]-fluoro-2-deoxyglucose (18F-FDG) PET-CT in patients with endocarditis on native valves according to the European Society of Cardiology 2015 (ESC 2015) modified diagnostic criteria of infective endocarditis classified as definite at three months of follow-up (baseline test). |
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| 详细说明 | Infectious endocarditis remains a serious pathology with an intra-hospital mortality of between 15 and 30%. The prognosis of patients depends on the speed of diagnosis and the beginning of the appropriate treatment. Currently, the diagnosis of endocarditis is based on the ESC 2015 modified criteria. Echocardiography techniques play a key role, but can be negative in 20% of endocarditis. 18F-FDG PET-CT showed promising results in the management of prosthetic valve endocarditis and / or stimulation material. However, few studies have been carried out on the contribution of PET-CT in the diagnosis of endocarditis on native valves, with discordant results. But this is the majority of endocarditis (70% of cases). A 18F-FDG PET-CT will be performed in all patients included in the study in addition to standard care for endocarditis, within 5 days of the beginning of their management in the university hospital center of Bordeaux after verification of inclusion and exclusion criteria and signature of consent. The included patients will be reviewed at Month 3 during a consultation with the completion of a clinical examination, an electrocardiogram, a biological assessment and a transthoracic ultrasound. Adverse events and serious adverse events will be collected throughout the study. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: Diagnostic study, prospective, "delayed-type cross-sectional study" (the result of the reference test is defined at 3 months of follow-up), monocentric, blinded, including consecutive patients. 盲法: Interventional 盲法描述:The interpretation of the PET-CT will be performed by a nuclear medicine expert who is expert in cardiac imaging and infectious pathology, blinded to other imaging tests. 主要目的: Diagnostic |
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| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
60 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | April 2020 | ||
| 预计主要完成日期 | April 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Any patient ≥ 18 years treated at the university hospital center of Bordeaux for suspicion of infectious endocarditis on a native valve with a "definite" or "possible" diagnosis according to the ESC 2015 modified diagnostic criteria, agreeing to participate, - Affiliated person or beneficiary of a social security scheme, - Free, informed and written consent (no later than the day of inclusion and before any exam required by the research). Exclusion Criteria: - Patient with a vital failure (haemodynamic, respiratory or neurological instability), requiring treatment in the intensive care unit and / or urgent surgery incompatible with performing PET-CT, - Pregnant or nursing woman, - Patient who has already been treated for infective endocarditis within six months of enrollment, - Patient who had cardiac surgery in the two months preceding inclusion, - Patient who has previously been hypersensitive to fluorodeoxyglucose and / or excipients of the radiotracer, - Patient unable to sign consent, - Patient under legal protection, - Women of childbearing age who do not benefit from effective contraception (HAS criteria), - Patient in a period of relative exclusion from another research protocol. | ||
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | France | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | University Hospital, Bordeaux | ||
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| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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