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

NCT02059551 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 887

Last updated 2022-05-13

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

MRI combined with venous ultrasonography of the legs

In case of positive D-dimer testing or in patients with a high probability of PE, MRI and a venous ultrasonography of the legs are done.MRI protocol includes 2 sequences: 1-Unenhanced steady-state-free precession sequences (SSFP) are acquired first without ECG-gating or breath-holding in the axial plane in the multiphase cine mode, with 6 phases per location.The acquisition is repeated to cover 2-3 of the thorax, from the roof of the aorta to the diaphragm. 2- A pulmonary gradient recalled echo (GRE) sequence is performed in the axial plane.The acquisition is triggered to start when contrast enhancement occurred in the right ventricle.Two acquisitions are necessary to cover the anatomy. For each acquisition, 0.15 mL kg-1 body weight of DOTAREM Gadolinium is injected at a rate of 3 mL s-1 followed by an injection of 15 mL of normal saline at 3 mL s-1.Venous ultrasonography of the legs: the examination consists of a real-time B-mode examination of the common femoral and popliteal veins.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • SANCHEZ Olivier, MD, PhD · Université Paris Descartes; Sorbonne Paris Cité; Service de Pneumologie et Soins Intensifs, Hôpital Européen Georges POmpidou; AP-HP

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2019-04-18
Completion
2019-04-18

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059551 on ClinicalTrials.gov