Diagnostic Performances of Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 887
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age > or = 18 years
- •clinical suspicion of PE
- •Affiliate (e) to a social security
- •provide written informed consent
Exclusion Criteria
- •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)
Arms & Interventions
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.
Intervention: MRI combined with venous ultrasonography of the legs (Procedure)
Outcomes
Primary Outcomes
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
Time Frame: 51 months
sensitivity, specificity, positive and negative likelihood ratios of the combination of MRI and venous ultrasonography of the legs
Secondary Outcomes
- 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)