Pulmonary EmbolismIRM-EP2NCT02059551
Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism
A study testing MRI combined with venous ultrasonography of the legs in people with Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Magnetic resonance imaging (MRI) represents a promising technique but can not be used as an alternative test to multidetector CT in patients with suspicion of pulmonary embolism (PE) due to its low sensitivity and high proportion of inconclusive MRI. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- MRI combined with venous ultrasonography of the legs
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 887 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to 18 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > or = 18 years
- clinical suspicion of PE
- Affiliate (e) to a social security
- provide written informed consent
Who cannot join
- Unstable patient clinically in shock on arrival at the emergency department
- Current pregnancy
- Life expectancy less than 3 months (eg terminal cancer)
- Follow up at 3 months impossible
- Anticoagulation curative> 48 hours prior to inclusion
- Cons-indication to spiral chest CT: allergy to contrast or creatinine clearance below 30 ml / min calculated by the Cockcroft
- Cons-indication to MRI claustrophobia, presence of intraocular metallic implant or a pacemaker, an allergy to gadolinium, morbid obesity (weight> 130 kg, anteroposterior> 60 cm diameter)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performances of Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism
Magnetic resonance imaging (MRI) represents a promising technique but can not be used as an alternative test to multidetector CT in patients with suspicion of pulmonary embolism (PE) due to its low sensitivity and high proportion of inconclusive MRI. The purpose of this study is to evaluate diagnostic performances of MRI combined with venous ultrasonography of the legs in patients with suspicion of PE.
- Conditions
- Pulmonary Embolism
- Being tested
- MRI combined with venous ultrasonography of the legs
- Keywords
- pulmonary embolism, magnetic resonance imaging, venous ultrasonography of the legs, diagnostic performances
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI combined with venous ultrasonography of the legsProcedure or surgery
In case of positive D-dimer testing or in patients with a high probability of PE, MRI and a venous ultrasonography of the legs are done.MRI protocol includes 2 sequences: 1-Unenhanced steady-state-free precession sequences (SSFP) are acquired first without ECG-gating or breath-holding in the axial plane in the multiphase cine mode, with 6 phases per location.The acquisition is repeated to cover 2-3 of the thorax, from the roof of the aorta to the diaphragm. 2- A pulmonary gradient recalled echo (GRE) sequence is performed in the axial plane.The acquisition is triggered to start when contrast enhancement occurred in the right ventricle.Two acquisitions are necessary to cover the anatomy. For each acquisition, 0.15 mL kg-1 body weight of DOTAREM Gadolinium is injected at a rate of 3 mL s-1 followed by an injection of 15 mL of normal saline at 3 mL s-1.Venous ultrasonography of the legs: the examination consists of a real-time B-mode examination of the common femoral and popliteal veins.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In case of positive D-dimer testing or in patients with a high clinical probability of PE, these patients have MRI protocol combined with venous ultrasonography of the legs. MRI includes 2 different sequences: Unenhanced steady-state-free precession sequences (SSFP) sequences and angiography sequences. (please see \\\"intervention section\\\" for more details). MRI readings will be performed centrally by two independent readers blinded to the results of diagnostic reference standard. Venous ultrasonography of the legs will be interpreted locally. Receives: Procedure: MRI combined with venous ultrasonography of the legs |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess diagnostic performances of MRI combined with venous ultrasonography of the legs in reference to Multi-Detector Computed Tomography and 3 months clinical follow-up
sensitivity, specificity, positive and negative likelihood ratios of the combination of MRI and venous ultrasonography of the legs
Measured: 51 months
Secondary outcomes (3)
To assess the diagnostic accuracy of a strategy combining clinical probability, D-dimer measurement, MRI and venous ultrasonography of the legs for PE
3-month thromboembolic events rate in patients who were left untreated on the basis of negative D-dimer measurement or negative combination of MRI + venous ultrasonography of the legs
Measured: 51 months
To assess diagnostic performances of each MRI sequence combined or not to venous ultrasonography of the legs in reference to Multi-Detector Computed Tomography and 3 months clinical follow-up
sensitivity, specificity, positive and negative likelihood ratios of each MRI sequence (unenhanced 2D steady-state-free-precession (SSFP) and contrast-enhanced 3D angiographic MR sequences) combined or not to venous ultrasonography of the legs in reference to Multi-Detector Computed Tomography and 3 months clinical follow-up
Measured: 51 months
inter-reader agreement for MRI
Kappa coefficient of concordance calculated on the diagnoses on MRI by two radiologists blinded to the diagnostic reference strategy (multidetector CT angiography and follow-up 3 months).
Measured: 51 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startAug 2013
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 887 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SANCHEZ Olivier, MD, PhD, Principal investigator, Université Paris Descartes; Sorbonne Paris Cité; Service de Pneumologie et Soins Intensifs, Hôpital Européen Georges POmpidou; AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059551
- Sponsor's protocol ID
- P120133
- Acronym
- IRM-EP2
- Status last verified
- Apr 2022
- First submitted
- 29 Jan 2014
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23652845Revel MP, Sanchez O, Couchon S, Planquette B, Hernigou A, Niarra R, Meyer G, Chatellier G. Diagnostic accuracy of magnetic resonance imaging for an acute pulmonary embolism: results of the 'IRM-EP' study. J Thromb Haemost. 2012 May;10(5):743-50. doi: 10.1111/j.1538-7836.2012.04652.x.
PubMed 22321816Stein PD, Chenevert TL, Fowler SE, Goodman LR, Gottschalk A, Hales CA, Hull RD, Jablonski KA, Leeper KV Jr, Naidich DP, Sak DJ, Sostman HD, Tapson VF, Weg JG, Woodard PK; PIOPED III (Prospective Investigation of Pulmonary Embolism Diagnosis III) Investigators. Gadolinium-enhanced magnetic resonance angiography for pulmonary embolism: a multicenter prospective study (PIOPED III). Ann Intern Med. 2010 Apr 6;152(7):434-43, W142-3. doi: 10.7326/0003-4819-152-7-201004060-00008.
PubMed 20368649
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performances of Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT02059551
- Acronym / sponsor ID
- IRM-EP2 / P120133
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, magnetic resonance imaging, venous ultrasonography of the legs, diagnostic performances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 887 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Magnetic resonance imaging (MRI) represents a promising technique but can not be used as an alternative test to multidetector CT in patients with suspicion of pulmonary embolism (PE) due to its low sensitivity and high proportion of inconclusive MRI. The purpose of this study is to evaluate diagnostic performances of MRI combined with venous ultrasonography of the legs in patients with suspicion of PE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: MRI combined with venous ultrasonography of the legsIn case of positive D-dimer testing or in patients with a high clinical probability of PE, these patients have MRI protocol combined with venous ultrasonography of the legs. MRI includes 2 different sequences: Unenhanced steady-state-free precession sequences (SSFP) sequences and angiography sequences. (please see \\\"intervention section\\\" for more details). MRI readings will be performed centrally by two independent readers blinded to the results of diagnostic reference standard. Venous ultrasonography of the legs will be interpreted locally. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > or = 18 years
- clinical suspicion of PE
- Affiliate (e) to a social security
- provide written informed consent
Key exclusion criteria (7 listed)
- Unstable patient clinically in shock on arrival at the emergency department
- Current pregnancy
- Life expectancy less than 3 months (eg terminal cancer)
- Follow up at 3 months impossible
- Anticoagulation curative> 48 hours prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI combined with venous ultrasonography of the legsIn case of positive D-dimer testing or in patients with a high probability of PE, MRI and a venous ultrasonography of the legs are done.MRI protocol includes 2 sequences: 1-Unenhanced steady-state-free precession sequences (SSFP) are acquired first without ECG-gating or breath-holding in the axial plane in the multiphase cine mode, with 6 phases per location.The acquisition is repeated to cover 2-3 of the thorax, from the roof of the aorta to the diaphragm. 2- A pulmonary gradient recalled echo (GRE) sequence is performed in the axial plane.The acquisition is triggered to start when contrast enhancement occurred in the right ventricle.Two acquisitions are necessary to cover the anatomy. For each acquisition, 0.15 mL kg-1 body weight of DOTAREM Gadolinium is injected at a rate of 3 mL s-1 followed by an injection of 15 mL of normal saline at 3 mL s-1.Venous ultrasonography of the legs: the examination consists of a real-time B-mode examination of the common femoral and popliteal veins. | Procedure or surgery | Intervention |
Primary outcome
To assess diagnostic performances of MRI combined with venous ultrasonography of the legs in reference to Multi-Detector Computed Tomography and 3 months clinical follow-up
Time frame: 51 months
sensitivity, specificity, positive and negative likelihood ratios of the combination of MRI and venous ultrasonography of the legs
3 secondary outcomes
To assess the diagnostic accuracy of a strategy combining clinical probability, D-dimer measurement, MRI and venous ultrasonography of the legs for PE
Time frame: 51 months
To assess diagnostic performances of each MRI sequence combined or not to venous ultrasonography of the legs in reference to Multi-Detector Computed Tomography and 3 months clinical follow-up
Time frame: 51 months
inter-reader agreement for MRI
Time frame: 51 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Background: PubMed 23652845Revel 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.
- Background: PubMed 22321816Revel MP, Sanchez O, Couchon S, Planquette B, Hernigou A, Niarra R, Meyer G, Chatellier G. Diagnostic accuracy of magnetic resonance imaging for an acute pulmonary embolism: results of the 'IRM-EP' study. J Thromb Haemost. 2012 May;10(5):743-50. doi: 10.1111/j.1538-7836.2012.04652.x.
- Background: PubMed 20368649Stein PD, Chenevert TL, Fowler SE, Goodman LR, Gottschalk A, Hales CA, Hull RD, Jablonski KA, Leeper KV Jr, Naidich DP, Sak DJ, Sostman HD, Tapson VF, Weg JG, Woodard PK; PIOPED III (Prospective Investigation of Pulmonary Embolism Diagnosis III) Investigators. Gadolinium-enhanced magnetic resonance angiography for pulmonary embolism: a multicenter prospective study (PIOPED III). Ann Intern Med. 2010 Apr 6;152(7):434-43, W142-3. doi: 10.7326/0003-4819-152-7-201004060-00008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SANCHEZ Olivier, MD, PhD principal investigator
Université Paris Descartes; Sorbonne Paris Cité; Service de Pneumologie et Soins Intensifs, Hôpital Européen Georges POmpidou; AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI combined with venous ultrasonography of the legs in people with Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess diagnostic performances of MRI combined with venous ultrasonography of the legs in reference to Multi-Detector Computed Tomography and 3 months clinical follow-up (time frame: 51 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02059551, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.