Magnetic Resonance Diagnosis of Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— IRM-EP  

Official title:

Magnetic Resonance Diagnosis of Pulmonary Embolism: Prospective Evaluation in 280 Patients, With Comparison to Multi-slice CT Angiography

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01077778
• Other study ID #: P051068
• Status: Terminated
• Phase: N/A
• First received: February 26, 2010
• Last updated: January 22, 2016
• Start date: March 2007
• Est. completion date: February 2010

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: February 2010
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Embolism
• Lung Diseases
• Pulmonary Embolism

Intervention

Procedure:
• Gadolinium-enhanced Magnetic Resonance Imaging
Gadolinium-enhanced Magnetic Resonance Imaging

Locations

Country	Name	City	State
France	Hopital George Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Blum A, Bellou A, Guillemin F, Douek P, Laprévote-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. — View Citation

Pleszewski B, Chartrand-Lefebvre C, Qanadli SD, Déry 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		17 months after the first inclusion	No
Secondary	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		3 months afer CTA	No