Prognostic of Annexin Imaging in Dissection of the Descending Aorta
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending
研究概览
简要总结
The relationship between the presence of a partial thrombus and aortic dilation after type B dissection has recently been reported. The originality lies in the idea of imaging thrombus activity to predict dilation after type B dissection. The innovative character is based on the use of annexin scintigraphy.
详细描述
To establish the proof of concept in humans of the link between the intensity of 99mTc-annexin V-128 binding in the descending thoracic aorta and the progression of aortic diameter in patients with type B aortic dissection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •patient whose age is ≥ 18 years old
- •any patient seen more than 6 months and less than 5 years after a dissection involving the descending aorta at Bichat Hospital, whether it is a dissection of the descending aorta alone or a dissection of the ascending aorta extended to the descending aorta
- •dissection of the uncomplicated descending thoracic aorta: not requiring surgery or stent implantation within the first 6 months after acute dissection
- •effective contraception for women of childbearing age
排除标准
- •scheduled procedure for dissection of the descending aorta
- •contraindication to aortic CT with injection of contrast media: renal failure with creatinine clearance <30 ml/min or creatinine >200 µmol/l; allergy to contrast media
- •history of surgery or stent implantation in the descending thoracic aorta
- •pregnant or breastfeeding women
- •patient under guardianship or trusteeship
- •non affiliation to social security or CMU (beneficiary or assignee)
- •patient refusal to participate in the study
研究组 & 干预措施
Annexin
All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)
干预措施: Annexin (Drug)
结局指标
主要结局
Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending
时间窗: 30 months
Pearson correlation coefficient between the rate of expansion of the aortic diameter measured by CT (at 6 months, 18 months and 30 months) in mm/year (at the site of maximum expansion) and the intensity of attachment of the annexin by the aortic wall descending in scintigraphy.
次要结局
- Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)(30 months)
- Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)(30 months)
- Determination of potential predictive biological factors of aortic dilation rate(30 months)
- Evaluation of the tolerance of the annexin scintigraphy by collecting side effects occurence(3 days)
- Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve.(30 months)
- Morphological characteristics of the wall thrombus(30 months)
- Determination of potential predictive clinical factors of aortic dilation rate(30 months)
- Determination of potential predictive morphological factors of aortic dilation rate(30 months)
- Number of cardiovascular events(30 months)
- Determination of potential predictive SPECT factors of aortic dilation rate(30 months)