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临床试验/NCT03683355
NCT03683355已完成不适用

Characterization of Radiolabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves. The COUNT Study. A Prospective, Observational Study.

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Radiolabeled tracer uptake grade (intense, moderate, mild or absent) in the prosthetic and periprosthetic areas.

研究概览

简要总结

Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer (18F-FDG) uptake in noninfected transcatheter heart valves in early follow-up after transcatheter aortic valve replacement (TAVR).

详细描述

Diagnostic accuracy of Infective endocarditis (IE) is commonly challenging. Current clinical guidelines recommend the use of the modified Duke criteria, based on clinical, echocardiographic and biological findings, as well as the results of blood cultures and serologies. Advances in imaging techniques have resulted in an improvement in the identification of endocardial involvements and extracardiac complications of IE. Thus, recent works have demonstrated that 18F-FDG PET/CT and radiolabeled leucocyte SPECT/CT may improve the detection of silent endocardial lesions. The sites of radiotracer accumulation show regions of a high metabolic activity due to an inflammation or infection process. It is well known that, in surgical prosthetic valves, a mild radiotracer uptake in the perivalvular area may occur in the absence of infection and could therefore be considered as a normal pattern, particularly early after valve replacement. However, evidence of this phenomenon is lacking regarding transcatheter heart valves and the factors used to distinguish between normal and abnormal patterns of radiolabeled tracer are not standardized. The hypothesis is that patients undergoing transcatheter aortic valve replacement (TAVR) show a radiolabeled tracer (18F-FDG) uptake around the prosthesis despite the absence of IE. Moreover, the uptake pattern might vary between different platforms.

Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer uptake in noninfected transcatheter heart valves in early follow-up after TAVR.

This will be a pilot study including 30 patients after TAVR procedure.

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

  • •Patients >18-year-old undergoing TAVR procedure with Edwards Sapien 3 and Core Valve Evolut R devices.
  • •Informed written consent

排除标准

  • •Inability to provide signed informed consent.
  • •Patients with definitive or possible IE according to modified Duke criteria and current clinical guidelines for the management of IE.
  • •Any contraindication for 18F-FDG PET/CT.
  • •Any condition making it unlikely the patient will be able to complete the protocol procedures and follow-up visits.

研究组 & 干预措施

Core Valve Evolut R

Patients who underwent transcatheter aortic valve replacement with the Core Valve Evolut R valve

干预措施: 18F-FDG PET/CT (Radiation)

Edwards Sapien 3

Patients who underwent transcatheter aortic valve replacement with the Edwards Sapien 3 valve

干预措施: 18F-FDG PET/CT (Radiation)

结局指标

主要结局

Radiolabeled tracer uptake grade (intense, moderate, mild or absent) in the prosthetic and periprosthetic areas.

时间窗: 3 months after TAVR

Visual analysis grading the radiolabeled tracer molecules uptake in the prosthetic and periprosthetic areas as intense, moderate, mild or absent. This visual analysis will be defined whether the PET/CT was positive (intense/moderate) or negative (mild/absent).

次要结局

  • Differences in radiolabeled tracer uptake grade in the prosthetic and periprosthetic areas between the Edwards valve versus the CoreValve valve.(3 months after TAVR)
  • Maximal standardized uptake value (SUVmax) using an average of 3 measurements from 3 volumes of interest (5mm3) introduced in the prosthetic region at equal distances from each other.(3 months after TAVR)
  • Correlation between radiolabeled tracer uptake grade and time from TAVR(3 months after TAVR)

研究者

发起方
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Rodes-Cabau

Principal Investigator

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

研究点 (1)

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