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Magnetic Resonance Diagnosis of Pulmonary Embolism (IRM-EP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01077778
Recruitment Status : Terminated (the number of patients will be included is reach)
First Posted : March 1, 2010
Last Update Posted : January 25, 2016
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
  • The purpose of this study is to evaluate the diagnostic accuracy of thoracic magnetic resonance imaging with gadolinium-enhanced, unenhanced and perfusion sequences in patients with clinically suspected acute pulmonary embolism
  • Thoracic CT angiography (CTA) will serve as reference standard
  • Result of MRI will not interfere with patients' management
  • Untreated patients with negative CTA will have 3-month follow-up to verify they were free of thrombose-embolic disease

Condition or disease Intervention/treatment
Lung Diseases Pulmonary Embolism Procedure: Gadolinium-enhanced Magnetic Resonance Imaging

Detailed Description:

Background In patients with clinically suspected pulmonary embolism (PE)°with a contraindication to thoracic CT angiography, there is a need for an alternative diagnostic procedure. MRI has not been fully evaluated in this field; moreover, recent technological advances make it necessary to re-evaluate its performance for PE diagnosis.

Design Prospective monocentric study

  • Patients with clinically suspected acute pulmonary embolism will undergo thoracic magnetic resonance imaging if inclusion criteria are fulfilled.
  • A non-inclusion register will be establish for patients fulfilling the inclusion criteria , not included because MRI was not available (off-hours presentation , another patients already included in the protocol on the same day )

Estimated enrolment : 280 (based on a 25% prevalence of PE in our institution and an expected 80% sensitivity of MRI) Study start date: June 2007 Estimated study completion date: 17 months later (40 to 50 presentations for PE suspicion each month, 20 inclusions expected per month)

Magnetic Resonance imaging: performed on a 1.5 Tesla unit with 3 different sequences

  • Unenhanced Steady State Free Precession (SSFP) sequences
  • Perfusion imaging following Gadolinium injection at a rate of 5 c/s and a dose of 0.1mmol/kg
  • Magnetic resonance angiography following an injection of 0.1mmol/kg of gadolinium at 3ml/s MRI studies will be interpreted secondarily by 2 independent radiologists, blinded to CTA results and clinical probability.

Two different readings will be performed, one global reading and one reading of each sequence separately, displayed in a random order (access base)


  • to evaluate MRI performance for PE diagnosis globally
  • to evaluate the diagnostic value for each sequence (especially the negative predictive value of a normal perfusion sequence)
  • to evaluate inter-observer agreement

MRI and CTA have to be performed within 24 hours

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Diagnosis of Pulmonary Embolism: Prospective Evaluation in 280 Patients, With Comparison to Multi-slice CT Angiography
Study Start Date : March 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Gadolinium-enhanced Magnetic Resonance Imaging
    Gadolinium-enhanced Magnetic Resonance Imaging

Primary Outcome Measures :
  1. MRI studies will be interpreted at the end of the inclusion process. CTA results will serve as reference standard to evaluate MRI sensitivity, specificity, positive and negative predictive values. Inter-observer agreement will be evaluated [ Time Frame: 17 months after the first inclusion ]

Secondary Outcome Measures :
  1. 3 months clinical follow-up will be performed in patients with negative CTA results who did not receive anticoagulation. This is to verify there were no false negatives on CTA [ Time Frame: 3 months afer CTA ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with acute pulmonary embolism suspicion who fulfil the inclusion criteria

Inclusion Criteria:

  • Clinically suspected acute pulmonary embolism
  • 18 years old or more
  • D-dimers more than 500 or high clinical probability of pulmonary embolism according to the revised Geneva score
  • Thoracic CT angiography performed within 24 hours
  • Informed consent

Exclusion Criteria:

  • - Contraindication to MRI (pace maker, claustrophobia, any implanted ferromagnetic foreign body)
  • Obese patients too large to fit in MRI unit
  • Allergy to gadolinium-containing contrast agent or to iodinated contrast media
  • Renal insufficiency (clearance less than 30 ml/mn)
  • Anticoagulation at a curative dose started more than 48 hours prior to MRI
  • Life expectancy less than 3 months
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01077778

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Hopital George Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Marie-pierre Revel, PH Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Aurélie Guimfack, Department Clinical Research of Developpement Identifier: NCT01077778    
Other Study ID Numbers: P051068
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: March 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Magnetic Resonance Imaging/methods
Magnetic Resonance Angiography
Perfusion Imaging
Pulmonary Embolism/diagnosis
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Embolism
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases