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

Assistance Publique - Hôpitaux de Paris1 site in 1 country887 target enrollmentAugust 2013

ConditionsPulmonary Embolism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Embolism
Sponsor: Assistance Publique - Hôpitaux de Paris
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
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

April 18, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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)