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Magnetic Resonance Diagnosis of Pulmonary Embolism (IRM-EP)

This study has been terminated.
(the number of patients will be included is reach)
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01077778
First received: February 26, 2010
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose
  • 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 Intervention
Lung Diseases
Pulmonary Embolism
 Procedure: Gadolinium-enhanced Magnetic Resonance Imaging

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Gadolinium
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: March 2007
Estimated Study Completion Date: February 2010
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Gadolinium-enhanced Magnetic Resonance Imaging
    Gadolinium-enhanced Magnetic Resonance Imaging
    Other Name: 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)

Objectives

  • 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with acute pulmonary embolism suspicion who fulfil the inclusion criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077778

Locations
France
Hopital George Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Marie-pierre Revel, PH Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Aurélie Guimfack, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT01077778     History of Changes
Other Study ID Numbers: P051068
Study First Received: February 26, 2010
Last Updated: February 26, 2010
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Magnetic Resonance Imaging/methods
Magnetic Resonance Angiography
Perfusion Imaging
Pulmonary Embolism/diagnosis

Additional relevant MeSH terms:
Embolism
Lung Diseases
Pulmonary Embolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013