Peripheral Arterial DiseaseAngioIRMNativeNCT01295554
Comparative Study of Non-enhanced Versus Contrast Enhanced MR Angiography in Peripheral Arterial Disease on a 3T MR Scanner.
An observational study of Peripheral Arterial Disease, run by Rennes University Hospital at 1 site in France.
Trial summary
Magnetic Resonance Angiography (MRA) of the peripheral arteries has become essential in the diagnosis and follow-up of peripheral arterial disease. In clinical routine, the acquisition uses intravenous injection of a Gadolinium based contrast agent (gadolinium chelates). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- NCE MRA and CE MRA
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Jan 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient known or clinically suspected to present a peripheral arterial disease
Who may be able to join
- Any adult patient known or clinically suspected to present a peripheral arterial disease, the assessment of which requires an MRA of the peripheral arteries.
- MRA will be prescribed by the vascular surgery or cardiology departments. The patient should be conscious and cooperative. Clear and intelligible oral and written information will be given to the patient. The patients giving written informed consent will be included in the study.
Who cannot join
- A contraindication to MRI, in particular pacemakers or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less than 6 weeks
- Contraindication to the injection of contrast agent: pregnancy, lactation, history of allergic reaction to contrast agent injection.
- Hemodynamically unstability, acute respiratory failure, a precarious condition or a need for continuous monitoring incompatible with the constraints of MR imaging.
- Age under 18 or under legal protection measure or without social coverage.
- A refusal or inability of obtaining informed consent from the patient.
- Patients withdrawing their informed consent will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Magnetic Resonance Angiography (MRA) of the peripheral arteries has become essential in the diagnosis and follow-up of peripheral arterial disease.
In clinical routine, the acquisition uses intravenous injection of a Gadolinium based contrast agent (gadolinium chelates).
Read more
Initially, contrast enhanced MR angiography (CE-MRA) was recommended for diabetic patients, elderly patients and\or patients with chronic renal insufficiency presenting a contraindication to CT angiography using iodized contrast agent injection.
However, the increase in nephrogenic systematic fibrosis clinical cases, which would be secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has restricted the use of CE-MRA. More than 500 cases were described to date in the world.
Its occurrence is currently estimated around 4 % for patients in terminal chronic renal insufficiency and its mortality around 30 %.
According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agents (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30 ml/mn.
Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide complete and non-invasive investigation of the peripheral vasculature, from the abdominal aorta to the calf, thus offering patients with chronic renal insufficiency a surrogate with no side effects.
Moreover, the use of high field (3T) MR imaging and phased array coils offers high quality images and good signal to noise ratio for peripheral vasculature analysis.
Besides, the acquisition can be repeated if required as it does not require any contrast injection.
The main objective is to evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf.
The secondary objective is to compare the diagnostic performances of NCE images with those of CE MRA.
The third objective is to estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images.
Read the detailed description
20 patients will be recruited either by the vascular surgery or by the cardiology departments The appointment for MRA of the peripheral arteries on the Siemens 3T MR Scanner will be given as usual.
- Conditions
- Peripheral Arterial Disease
- Being tested
- NCE MRA and CE MRA
- Keywords
- Peripheral arterial disease, MRA
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCE MRA and CE MRAOther
Each patient will receive on the same day:
- NCE MRA
- CE MRA usually performed in the clinical routine
After each MRA examination, the CE images will be interpreted by a radiologist and the report transmitted to the prescriber within the usual delay. The radiologists in charge of this interpretation will not be involved in the evaluation of NCE images nor in the comparison between CE and NCE images.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral arterial disease | Peripheral arterial disease Receives: Other: NCE MRA and CE MRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf.
To evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf.
Measured: 5 months
Secondary outcomes (2)
To compare the diagnostic performances of NCE images with those of CE MRA.
To compare the diagnostic performances of NCE images with those of CE MRA.
Measured: 5 months
To estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images.
To estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Gandon, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295554
- Sponsor's protocol ID
- LOC/10-03 - AngioIRM-Native
- Other IDs
- 2010-A00342-37
- Acronym
- AngioIRMNative
- Status last verified
- Feb 2012
- First submitted
- 11 Feb 2011
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Non-enhanced Versus Contrast Enhanced MR Angiography in Peripheral Arterial Disease on a 3T MR Scanner.
- ClinicalTrials.gov ID
- NCT01295554
- Acronym / sponsor ID
- AngioIRMNative / LOC/10-03 - AngioIRM-Native
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral arterial disease, MRA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Feb 2011 (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 Angiography (MRA) of the peripheral arteries has become essential in the diagnosis and follow-up of peripheral arterial disease.
In clinical routine, the acquisition uses intravenous injection of a Gadolinium based contrast agent (gadolinium chelates).
Initially, contrast enhanced MR angiography (CE-MRA) was recommended for diabetic patients, elderly patients and\or patients with chronic renal insufficiency presenting a contraindication to CT angiography using iodized contrast agent injection.
However, the increase in nephrogenic systematic fibrosis clinical cases, which would be secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has restricted the use of CE-MRA. More than 500 cases were described to date in the world.
Its occurrence is currently estimated around 4 % for patients in terminal chronic renal insufficiency and its mortality around 30 %.
According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agents (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30 ml/mn.
Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide complete and non-invasive investigation of the peripheral vasculature, from the abdominal aorta to the calf, thus offering patients with chronic renal insufficiency a surrogate with no side effects.
Moreover, the use of high field (3T) MR imaging and phased array coils offers high quality images and good signal to noise ratio for peripheral vasculature analysis.
Besides, the acquisition can be repeated if required as it does not require any contrast injection.
The main objective is to evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf.
The secondary objective is to compare the diagnostic performances of NCE images with those of CE MRA.
The third objective is to estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images.
Detailed description
20 patients will be recruited either by the vascular surgery or by the cardiology departments The appointment for MRA of the peripheral arteries on the Siemens 3T MR Scanner will be given as usual.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral arterial disease | – | Other: NCE MRA and CE MRAPeripheral arterial disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient known or clinically suspected to present a peripheral arterial disease
Key inclusion criteria (2 listed)
- Any adult patient known or clinically suspected to present a peripheral arterial disease, the assessment of which requires an MRA of the peripheral arteries.
- MRA will be prescribed by the vascular surgery or cardiology departments. The patient should be conscious and cooperative. Clear and intelligible oral and written information will be given to the patient. The patients giving written informed consent will be included in the study.
Key exclusion criteria (6 listed)
- A contraindication to MRI, in particular pacemakers or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less than 6 weeks
- Contraindication to the injection of contrast agent: pregnancy, lactation, history of allergic reaction to contrast agent injection.
- Hemodynamically unstability, acute respiratory failure, a precarious condition or a need for continuous monitoring incompatible with the constraints of MR imaging.
- Age under 18 or under legal protection measure or without social coverage.
- A refusal or inability of obtaining informed consent from the patient.
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 |
|---|---|---|
| NCE MRA and CE MRAEach patient will receive on the same day: * NCE MRA * CE MRA usually performed in the clinical routine After each MRA examination, the CE images will be interpreted by a radiologist and the report transmitted to the prescriber within the usual delay. The radiologists in charge of this interpretation will not be involved in the evaluation of NCE images nor in the comparison between CE and NCE images. | Other | Peripheral arterial disease |
Primary outcome
To evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf.
Time frame: 5 months
To evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf.
2 secondary outcomes
To compare the diagnostic performances of NCE images with those of CE MRA.
Time frame: 5 months
To estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images.
Time frame: 5 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 Feb 2012.
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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.
Yves Gandon, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Rennes University Hospital 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 2 inclusion and 6 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 Feb 2012. 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 evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2012.