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

NCT01295554 | Completed

• 2 other identifiers: LOC/10-03 - AngioIRM-Native2010-A00342-37
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial disease, MRA

Outcome Measures

Primary Outcomes (1)

• 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.

  5 months

Secondary Outcomes (2)

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

  5 months

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

  5 months

Study Arms (1)

Peripheral arterial disease

Peripheral arterial disease

Other: NCE MRA and CE MRA

Interventions

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.

Peripheral arterial disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient known or clinically suspected to present a peripheral arterial disease

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, France, 35000, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Yves Gandon, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 14, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 13, 2012

Record last verified: 2012-02

Locations

FR (1)