* 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
Study Type
OBSERVATIONAL
Enrollment
300
Gadolinium-enhanced Magnetic Resonance Imaging
Hopital George Pompidou
Paris, France
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
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
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