Magnetic Resonance Diagnosis of Pulmonary Embolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-02-28

Brief Summary

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* 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

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Detailed Description

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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

Conditions

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Lung Diseases Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Gadolinium-enhanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No