Ignite Creation Date:
2024-05-05 @ 11:16 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01295554
Status:
COMPLETED
Last Update Posted:
2012-02-13
First Post:
2011-02-11
Brief Title:
Comparative Study of Non-enhanced Versus Contrast Enhanced MR Angiography in Peripheral Arterial Disease on a 3T MR Scanner
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Comparative Study of Non-enhanced Versus Contrast Enhanced MR Angiography in Peripheral Arterial Disease on a 3T MR Scanner
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AngioIRMNative
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 andor 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 mlmn
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
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 andor 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 mlmn
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-A00342-37 | OTHER | ID RCB from AFSSAPS | None |