NCT04792281招募中不适用
Impact of FDG-PET/CT on Management of Patients with Native Valve Infective Endocarditis
Montreal Heart Institute6 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2021年8月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 97
- 试验地点
- 6
- 主要终点
- Proportion of patients with Possible IE that will be appropriately reclassified
研究概览
简要总结
The proposed study is a multicentric prospective observational cohort study of patients with suspected NVE. The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 6 participating sites which include 2 cardiac centers, the MHI and the IUCPQ, as well as 4 tertiary care centers, the Jewish General Hospital , the McGill University Health Centre and the CHUS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or older, capable to provide informed consent;
- •Referred for a FDG-PET/CT study
- •Classified as having Possible IE prior to FDG-PET/CT imaging;
- •Patients must be able to tolerate the physical/logistical requirements of a PET/CT scan.
排除标准
- •Subjects with prosthetic cardiac valve and/or CIED;
- •Pregnant or breastfeeding female;
- •Body mass index > 45 kg/m2.
结局指标
主要结局
Proportion of patients with Possible IE that will be appropriately reclassified
时间窗: 3 months
Proportion of patients with Possible IE that will be appropriately reclassified as Definite IE by the addition of FDG-PET to the Duke criteria.
次要结局
- Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET but excluding TEE for the detection of NVE(3 months)
- Proportion of patients with final diagnosis of IE with septic emboli detected on whole body FDGPET(3 months)
- Differences target-to-background ratio (TBR) between infected and non-infected valves(3 months)
- Sensitivity, specificity, and accuracy of FDG-PET for the detection of NVE(3 months)
- Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET for detection of NVESensitivity, specificity, and accuracy of the Duke criteria with FDG-PET for detection of NVE(3 months)
- Differences in maximal standardized uptake value (SUVmax) between infected and non-infected valves(3 months)
- Proportion of patients in whom a TEE was not necessary to diagnose NVE through the addition of FDG-PET(3 months)
- Differences in the rate of sub-optimal suppression protocol between males and females(3 months)
- Proportion of patients with incidental cancer identified on FDG-PET(3 months)
研究者
Matthieu Pelletier-Galarneau, MD MSc
Assistant Professor
Montreal Heart Institute
研究点 (6)
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