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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

February 26, 2010
February 26, 2010
March 2007
September 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Magnetic Resonance Diagnosis of Pulmonary Embolism
Magnetic Resonance Diagnosis of Pulmonary Embolism: Prospective Evaluation in 280 Patients, With Comparison to Multi-slice CT Angiography
  • 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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

patients with acute pulmonary embolism suspicion who fulfil the inclusion criteria

  • Lung Diseases
  • Pulmonary Embolism
Procedure: Gadolinium-enhanced Magnetic Resonance Imaging
Gadolinium-enhanced Magnetic Resonance Imaging
Other Name: Gadolinium-enhanced Magnetic Resonance Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
February 2010
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01077778
P051068
No
Aurélie Guimfack, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Marie-pierre Revel, PH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

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