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
- 否
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
研究点 (4)
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