跳至主要内容
临床试验/NCT01984905
NCT01984905终止不适用

Exploratory Study of Prognostic Factors in Aortic Dissection Type B: Role of Imaging (18F-FDG PET-Scan and Angioscan) and Biomarkers

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
1
主要终点
Correlation between the increase in the aortic diameter and the intensity of 18-FDG binding (Standard Uptake Value) at 1 year

研究概览

简要总结

Clinical outcomes of chronic type B aortic dissections are unknown, especially in case of false lumen expansion and risk of rupture. Data of literature give us some indications about prognosis. The 1-year survival rate is about 80%, but we deplore the 25% rate of mortality at 3 years despite follow-up.The only known predictive factors are the initial diameter of more than 4 cm and the persistence of a false lumen patent.However, actual means of follow-up do not allow to predict severe complications. The aim of the sudy is to propose a diagnostic and preventive strategy for the follow-up of chronic type B aortic dissections treated medically.

The primary objective is then to evaluate the prognostic role of 18-FDG-PET Scan in such patients in order to predict the risk of aortic diameter growth of more than 5 mm in 1 year and/or of an aortic dissections extension at 1 year. The secondary objectives are to evaluate the link between fibrosis biomarkers MMP et TIMP) and the results of imaging results (evolution of diameter and extension and results of PET-Scan imaging) Methods: 100 patients to be included in 3 years History of chronic type B aortic dissection, treated medically, evolving since more than 1 month and less than 5 years.

Expected results: Prognostic contribution of 18FDG-PET-Scan and biomarkers for the identification of patients at high risk of evolution. Elaboration of a decisional algorithm about follow-up modalities of chronic aortic dissections. Demonstration of a correlation between aortic diameter growth or aortic dissection extension and intensity of marker fixation with 18-FDG-PET-Scan.

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

入选标准

  • Patients over 18 years old
  • Chronic type B aortic dissection, without surgical treatment
  • Medically treated patient
  • Medical treatment since more than 1 month and less than 5 years
  • Aortic dissection localization : below left subclavian artery and alow femoral artery
  • Affiliation to a social security system
  • Patient who have given informed consent

排除标准

  • History of malignant pathology
  • Aortic dissection since less than 1 month or more than 5 years
  • Inflammatory or infectious disease of the aorta
  • Uncontrolled infectious disease
  • Iodine Allergy
  • Severe renal insufficiency (cockcroft clearance <30 mL/min)
  • Patient under guardianship or curators
  • Any associated medical or psychological condition wich could compromise the patient's ability to participate in the study
  • Inability to be submitted to the study follow-up for geographical, social or psychological reasons
  • Current pregnancy or lack of effective contraception during their reproductive years

结局指标

主要结局

Correlation between the increase in the aortic diameter and the intensity of 18-FDG binding (Standard Uptake Value) at 1 year

时间窗: 1 year

次要结局

  • Correlation between biomarkers of fibrosis and results of morphological and functional imaging(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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