Diagnostic Performances of Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 887
- 试验地点
- 1
- 主要终点
- To assess diagnostic performances of MRI combined with venous ultrasonography of the legs in reference to Multi-Detector Computed Tomography and 3 months clinical follow-up
研究概览
简要总结
Magnetic resonance imaging (MRI) represents a promising technique but can not be used as an alternative test to multidetector CT in patients with suspicion of pulmonary embolism (PE) due to its low sensitivity and high proportion of inconclusive MRI. The purpose of this study is to evaluate diagnostic performances of MRI combined with venous ultrasonography of the legs in patients with suspicion of PE.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > or = 18 years
- •clinical suspicion of PE
- •Affiliate (e) to a social security
- •provide written informed consent
排除标准
- •Unstable patient clinically in shock on arrival at the emergency department
- •Current pregnancy
- •Life expectancy less than 3 months (eg terminal cancer)
- •Follow up at 3 months impossible
- •Anticoagulation curative> 48 hours prior to inclusion
- •Cons-indication to spiral chest CT: allergy to contrast or creatinine clearance below 30 ml / min calculated by the Cockcroft
- •Cons-indication to MRI claustrophobia, presence of intraocular metallic implant or a pacemaker, an allergy to gadolinium, morbid obesity (weight> 130 kg, anteroposterior> 60 cm diameter)
研究组 & 干预措施
Intervention
In case of positive D-dimer testing or in patients with a high clinical probability of PE, these patients have MRI protocol combined with venous ultrasonography of the legs. MRI includes 2 different sequences: Unenhanced steady-state-free precession sequences (SSFP) sequences and angiography sequences. (please see \\\"intervention section\\\" for more details). MRI readings will be performed centrally by two independent readers blinded to the results of diagnostic reference standard. Venous ultrasonography of the legs will be interpreted locally.
干预措施: MRI combined with venous ultrasonography of the legs (Procedure)
结局指标
主要结局
To assess diagnostic performances of MRI combined with venous ultrasonography of the legs in reference to Multi-Detector Computed Tomography and 3 months clinical follow-up
时间窗: 51 months
sensitivity, specificity, positive and negative likelihood ratios of the combination of MRI and venous ultrasonography of the legs
次要结局
- To assess the diagnostic accuracy of a strategy combining clinical probability, D-dimer measurement, MRI and venous ultrasonography of the legs for PE(51 months)
- inter-reader agreement for MRI(51 months)
- To assess diagnostic performances of each MRI sequence combined or not to venous ultrasonography of the legs in reference to Multi-Detector Computed Tomography and 3 months clinical follow-up(51 months)