Magnetic Resonance Diagnosis of Pulmonary Embolism (IRM-EP)

January 22, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • hôpital george Pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with acute pulmonary embolism suspicion who fulfil the inclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
17 months after the first inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months afer CTA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Marie-pierre Revel, PH, Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (Estimate)

March 1, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P051068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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