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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 22, 2014