NCT01077778

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
Last Updated

January 25, 2016

Status Verified

March 1, 2007

Enrollment Period

6 months

First QC Date

February 26, 2010

Last Update Submit

January 22, 2016

Conditions

Lung DiseasesPulmonary Embolism

Keywords

Magnetic Resonance Imaging/methodsMagnetic Resonance AngiographyPerfusion ImagingPulmonary Embolism/diagnosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Interventions

Gadolinium-enhanced Magnetic Resonance ImagingPROCEDURE

Gadolinium-enhanced Magnetic Resonance Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with acute pulmonary embolism suspicion who fulfil the inclusion criteria

You may qualify if:

  • Clinically suspected acute pulmonary embolism
  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital George Pompidou

Paris, 75015, France

Location

Related Publications (3)

  • 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.

    PMID: 15735802BACKGROUND

  • 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.

    PMID: 16632150BACKGROUND

  • 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.

    PMID: 23652845DERIVED

MeSH Terms

Conditions

Lung DiseasesPulmonary EmbolismDisease

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-pierre Revel, PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 1, 2010

Study Start

March 1, 2007

Primary Completion

September 1, 2007

Study Completion

February 1, 2010

Last Updated

January 25, 2016

Record last verified: 2007-03

Locations

FR(1)