Clinical trial NCT01077778: Magnetic Resonance Diagnosis of Pulmonary Embolism
Official title: Magnetic Resonance Diagnosis of Pulmonary Embolism: Prospective Evaluation in 280 Patients, With Comparison to Multi-slice CT Angiography
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Diseases
Pulmonary Embolism
Keywords: Magnetic Resonance Imaging/methods
Magnetic Resonance Angiography
Perfusion Imaging
Pulmonary Embolism/diagnosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-03-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute pulmonary embolism suspicion who fulfil the inclusion criteria

Brief summary: * 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

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 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

Primary outcomes:
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
timeFrame: 17 months after the first inclusion
Secondary outcomes:
measure: 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
timeFrame: 3 months afer CTA
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital George Pompidou
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie-pierre Revel, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blum A, Bellou A, Guillemin F, Douek P, Laprevote-Heully MC, Wahl D; GENEPI study group. Performance of magnetic resonance angiography in suspected acute pulmonary embolism. Thromb Haemost. 2005 Mar;93(3):503-11. doi: 10.1160/TH04-08-0495.
citation: Pleszewski B, Chartrand-Lefebvre C, Qanadli SD, Dery R, Perreault P, Oliva VL, Prenovault J, Belblidia A, Soulez G. Gadolinium-enhanced pulmonary magnetic resonance angiography in the diagnosis of acute pulmonary embolism: a prospective study on 48 patients. Clin Imaging. 2006 May-Jun;30(3):166-72. doi: 10.1016/j.clinimag.2005.10.005.
citation: Revel MP, Sanchez O, Lefort C, Meyer G, Couchon S, Hernigou A, Niarra R, Chatellier G, Frija G. Diagnostic accuracy of unenhanced, contrast-enhanced perfusion and angiographic MRI sequences for pulmonary embolism diagnosis: results of independent sequence readings. Eur Radiol. 2013 Sep;23(9):2374-82. doi: 10.1007/s00330-013-2852-8. Epub 2013 May 8.