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Completed

NCT Number: NCT02059551

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

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI combined with venous ultrasonography of the legs

Procedure

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.

Primary outcomes

  1. 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

  1. To assess the diagnostic accuracy of a strategy combining clinical probability, D-dimer measurement, MRI and venous ultrasonography of the legs for PE

    Time frame: 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

  2. 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

    Time frame: 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

  3. inter-reader agreement for MRI

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: IRM-EP2

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2014
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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