Assessment of Thrombus Stiffness Using Ultrasound Elastography in Venous Thrombo-embolism.
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Shear Wave Speed within the thrombus.
研究概览
简要总结
Venous Thrombo-Embolic Disease (VTED) is a serious and common ailment, defined by the growth of a clot - or thrombus - in a vein, and/or as the migration of this thrombus to a pulmonary artery. It represents the third cause of death after cardio-vascular disease and cancer, and encompass superficial, muscular and Deep Venous Thrombosis (DVT), and Pulmonary Embolisms (PE), which can be isolated or associated.
Ultrasound is today the most frequently used exam to diagnose DVT. However, it's unable to provide information on thrombus age or cause.
Elastography is an imaging technic which aims to analyse elastic properties of a tissue, by applying a mechanical impulse on it, and could be an interesting tool in thrombus exploration, and provide additional information.
详细描述
Proximal deep venous thrombosis of a lower limb was defined as any venous thrombosis involving the ilio-femoral and/or femoro-popliteal axes, with or without cava thrombosis or distal DVT.
A DVT was assumed provoked, as recommended by AFSSAPS (2009) and ACCP (2012), when there was a major transient risk factor (surgery, prolonged immobilization ≥3 days, lower limb fracture) in the last three months, or a persistent risk factor (Antiphospholipid syndrome, active cancer). In case of absence of at least one of these factors, DVT was considered unprovoked.
A DVT was supposed recent when there was no known DVT in the patient medical history.
The association with a Pulmonary Embolism was assessed by the presence of PE diagnosis in the medical report. It had to be diagnosed following the ESC guidelines, with a thoracic CT scan and/or a V/Q lung scan.
In this study, we analysed the shear wave's velocity (expressed in m/s).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Over 18 years old.
- •Suffering from a proximal DVT (DVT) of at least one lower limb.
- •Thrombosis is assumed to be recent (no history of ipsilateral DVT).
- •Non opposition obtained.
排除标准
- •Patient suffering from an inferior vena cava thrombosis with no extension to ilio-femoral veins.
- •Physical or cognitive inability to consent.
- •Patient refusal.
结局指标
主要结局
Shear Wave Speed within the thrombus.
时间窗: At VTE diagnostic (Day 0)
Quantitative data, in meter per second.
次要结局
未报告次要终点