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Completed

NCT Number: NCT01295554

Comparative Study of Non-enhanced Versus Contrast Enhanced MR Angiography in Peripheral Arterial Disease on a 3T MR Scanner.

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes University Hospital

Rennes, France, 35000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

NCE MRA and CE MRA

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. To compare the diagnostic performances of NCE images with those of CE MRA.

    Time frame: 5 months

    To compare the diagnostic performances of NCE images with those of CE MRA.

  2. To estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images.

    Time frame: 5 months

    To estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: AngioIRMNative

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 14, 2011
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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