Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism (IRM-EP2)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Procedure: MRI combined with venous ultrasonography of the legs

Study type: Interventional

Funder types: Other

Identifiers

NCT02059551

P120133

Details and patient eligibility

About

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.

Enrollment: 887 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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887 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Procedure: MRI combined with venous ultrasonography of the legs