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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02059551
First received: January 29, 2014
Last updated: February 7, 2014
Last verified: August 2013

January 29, 2014
February 7, 2014
August 2013
August 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
sensitivity, specificity, positive and negative likelihood ratios of the combination of MRI and venous ultrasonography of the legs
Same as current
Complete list of historical versions of study NCT02059551 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: No ]
    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
  • inter-reader agreement for MRI [ Time Frame: 51 months ] [ Designated as safety issue: No ]
    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).
Same as current
Not Provided
Not Provided
 
Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism
Diagnostic Performances of 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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pulmonary Embolism
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.
Experimental: Intervention
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.
Intervention: Procedure: MRI combined with venous ultrasonography of the legs

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1058
Not Provided
August 2016   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: SANCHEZ Olivier, MD, PhD +33156093487 olivier.sanchez@egp.aphp.fr
France
 
NCT02059551
P120133
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: SANCHEZ Olivier, MD, PhD Université Paris Descartes; Sorbonne Paris Cité; Service de Pneumologie et Soins Intensifs, Hôpital Européen Georges POmpidou; AP-HP
Assistance Publique - Hôpitaux de Paris
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP