Not provided
Not provided
Not provided
Not provided
Not provided
the number of patients will be included is reach
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Two different readings will be performed, one global reading and one reading of each sequence separately, displayed in a random order (access base)
Objectives
MRI and CTA have to be performed within 24 hours
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadolinium-enhanced Magnetic Resonance Imaging | Procedure | Gadolinium-enhanced Magnetic Resonance Imaging |
| Measure | Description | 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 | 17 months after the first inclusion |
| Measure | Description | 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 | 3 months afer CTA |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
patients with acute pulmonary embolism suspicion who fulfil the inclusion criteria
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marie-pierre Revel, PH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital George Pompidou | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15735802 | Background | 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. | |
| 16632150 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D011655 | Pulmonary Embolism |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 23652845 | Derived | 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. |
| D002318 |
| Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |