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