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

Peripheral Arterial Disease Clinical Trial

— AngioIRMNative  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295554
• Other study ID #: LOC/10-03 - AngioIRM-Native
• Secondary ID: 2010-A00342-37
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: February 10, 2012
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	5 months	No
Secondary	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.	5 months	No