To Assess the Value of 3D Time-of-Flight Magnetic Resonance Angiography in Hemodialysis Patients With Occlusive Disease in Arteriovenous Fistula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- stenosis location
研究概览
简要总结
This study is aimed to assess the value of three-dimensional time-of-flight magnetic resonance angiography (3D-TOF-MRA) in hemodialysis patients with occlusive disease in arteriovenous fistula (AVF). All participants will receive 3D-TOF-MRA and ultrasound to detect the stenosis degree of AVF.
详细描述
The Principle of 3D-TOF-MRA is based on the "flow effect" of MR. In the GE sequence of MRA imaging, the effect of RF pulses makes the protons in the stationary tissue in the active layer in a saturated state, and the longitudinal magnetization disappears. When the inflow blood appears, its protons are in an unsaturated state and have a high degree of longitudinal magnetization. In this way, a clear difference is formed between saturated tissue and unsaturated flowing blood to display blood vessels. Therefore as a non-invasive and safe method for diagnosing vascular diseases, 3D-TOF-MRA is used widely in cerebrovascular diseases. However, there are currently no studies using 3D-TOF-MRA to diagnose arteriovenous fistula (AVF) stenosis in hemodialysis patients. This project plans to use 3D-TOF-MRA to detect AVF stenosis in hemodialysis patients to provide a safe and effective diagnostic method for patients with end-stage renal failure.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemodialysis patients suspected of occlusive disease in arteriovenous fistula (AVF);
- •persistent edema of the limb with the fistula;
- •decreased pulse or fremitus in anastomotic astium
- •increase in venous pressure; blood flow at the access of less than 200 mL/min;
排除标准
- •previous endovascular recanalization with stent or graft placement;
- •contraindications to magnetic resonance imaging (MRI) examination;
- •platelet(PLT)<60*10^9/L or international normalized ratio (INR)>1.5;
- •important organ function failure or other serious illness;
- •Allergic to antiplatelet drug, anticoagulant drug, anaesthetic drug and contrast material.
研究组 & 干预措施
intervention
All participants received 3D-TOF-MRA and ultrasound examination, and DSA is used as golden reference
干预措施: 3D-TOF-MRA (Diagnostic Test)
结局指标
主要结局
stenosis location
时间窗: immediately after examination finished
1. = arterial vessel of AVF 2. = orifice of AVF 3. = venous vessel of AVF
degree of stenosis
时间窗: immediately after examination finished
visual grading system: 0 = completely smooth vessel wall; 1. = \<50% stenosis; 2. = 50%-75% stenosis; 3. = 75%-99% stenosis; 4. = occlusion.
次要结局
未报告次要终点
研究者
Yueqi Zhu
Clinical Professor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital