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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01295554
First received: February 11, 2011
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Other: NCE MRA and CE MRA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparative Study of Non-enhanced Versus Contrast Enhanced MR Angiography in Peripheral Arterial Disease on a 3T MR Scanner.

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • To evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    To evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf.


Secondary Outcome Measures:
  • To compare the diagnostic performances of NCE images with those of CE MRA. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    To compare the diagnostic performances of NCE images with those of CE MRA.

  • To estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    To estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images.


Enrollment: 22
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Peripheral arterial disease
Peripheral arterial disease
Other: NCE MRA and CE MRA

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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patient known or clinically suspected to present a peripheral arterial disease

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295554

Locations
France
Rennes University Hospital
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Yves Gandon, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01295554     History of Changes
Other Study ID Numbers: LOC/10-03 - AngioIRM-Native, 2010-A00342-37
Study First Received: February 11, 2011
Last Updated: February 10, 2012
Health Authority: France: Institutional Ethical Committee

Keywords provided by Rennes University Hospital:
Peripheral arterial disease, MRA

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014