跳至主要内容
临床试验/NCT02182908
NCT02182908已完成不适用

ANALYSE EN MORPHO-TEP AU FDG DE L'EVOLUTIVITE DES ANEVRISMES ABDOMINAUX AORTIQUES NON CHIRURGICAUX UNE ETUDE MULTICENTRIQUE DE L'INTER-REGION NORD-EST

Central Hospital, Nancy, France4 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2007年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
4
主要终点
Association between overall baseline 18-FDG uptake intensity of the aneurysm and its 9-month maximal diameter and/or volume in patients with diameter change greater than 4 mm/year

研究概览

简要总结

The primary aim of the study is to determine if the evolutivity of global and segmentary captation of FDG-F18, which can be measured in the wall of abdominal aorta aneurysm, is predictive of the 9 month evolution of diameter and volume of the aneurysm, measured globally and segmentary in angioscan.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
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

入选标准

  • AAA with a minimum diameter of 40 mm, calculated with a standardized method
  • No indication for an immediate surgery or endoprothesis implantation
  • Age above 18 (except for patient under supervision)
  • Patient having read the information letter and signed the informed consent

排除标准

  • AAA should have no other specific cause than atherosclerosis

结局指标

主要结局

Association between overall baseline 18-FDG uptake intensity of the aneurysm and its 9-month maximal diameter and/or volume in patients with diameter change greater than 4 mm/year

时间窗: 9 months

Composite primary outcome.

次要结局

  • Contribution of overall 18-FDG uptake to the predictive values of other baseline characteristics of the aneurysm (diameter, volume, thickness and wall stress, clinical and biological values)(9 months)
  • Association between 9-month overall 18-FDG uptake change and variation of plasmatic biomarkers of inflammation, proteolysis and coagulation.(9 months)
  • Association between initial 18-FDG uptake of individual aneurysmal segments and their 9-month diameter change.(9 months)
  • Association between overall 18-FDG uptake and other baseline characteristics of the aneurysm (diameter, volume, thickness and wall stress, clinical and biological values).(9 months)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (4)

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