Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism

Not Applicable

Completed

• Conditions: Pulmonary Embolism
• Interventions: Procedure: MRI combined with venous ultrasonography of the legs

• Registration Number: NCT02059551
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-11
• Primary Completion: 2019-04-18
• Study Completion: 2019-04-18
• Status Verified: 2022-04
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 887

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	MRI combined with venous ultrasonography of the legs	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.

Primary Outcome Measures

Name	Time	Method
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	51 months	sensitivity, specificity, positive and negative likelihood ratios of the combination of MRI and venous ultrasonography of the legs

Secondary Outcome Measures

Name	Time	Method
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	3-month thromboembolic events rate in patients who were left untreated on the basis of negative D-dimer measurement or negative combination of MRI + venous ultrasonography of the legs
inter-reader agreement for MRI	51 months	Kappa coefficient of concordance calculated on the diagnoses on MRI by two radiologists blinded to the diagnostic reference strategy (multidetector CT angiography and follow-up 3 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	sensitivity, specificity, positive and negative likelihood ratios of each MRI sequence (unenhanced 2D steady-state-free-precession (SSFP) and contrast-enhanced 3D angiographic MR sequences) combined or not to venous ultrasonography of the legs in reference to Multi-Detector Computed Tomography and 3 months clinical follow-up

Trial Locations

Locations (1)

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France