Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA.
研究概览
简要总结
To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using two different magnetic resonance contrast agents.
详细描述
Atherosclerosis of the lower leg arteries is a common disease. Patients with this condition has symptoms of ischemia, for instance intermittent claudication (pain during exercise). Diagnosis of atherosclerosis in the legs is normally done with an interventional x-ray-based angiography (DSA- digital subtraction angiography). This is uncomfortable for the patient, and associated with risks of complications (bleeding, vascular damage, embolism).A novel approach to diagnosing atherosclerosis is the use of magnetic resonance angiography. A variant of this is the whole body magnetic resonance angiography(WB-MRA), that produce a picture of the arteries in almost the whole body (excluding the coronary arteries). WB-MRA has a number of advantages compared to DSA. It does not use ionizing radiation, is not invasive, uses a contrast medium with fewer side affects and finally gives a covers a great deal of the arteries in the body.
This study will compare WB-MRA with DSA in patients with symptoms of peripheral atherosclerosis in the lower legs. We will investigate 2 different contrast agents used for WB-MRA. The patients will be randomized to receive either the contrast medium Dotarem or the contrast medium Vasovist. In both groups we will compare the results of WB-MRA with DSA.
研究设计
- 研究类型
- Observational
- 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
- •Symptomatic lower extremity ischemia (claudication, ischemic wounds)
- •Referred to digital subtraction angiography (DSA)
排除标准
- •Renal insufficiency (GFR < 30 ml/min)
- •Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)
- •Pregnancy/lactation
- •Allergy to gadolinium based MRI contrast agents
- •Acute disease
结局指标
主要结局
Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA.
次要结局
未报告次要终点
