Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)
- Registration Number
- NCT00707876
- Lead Sponsor
- AMAG Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to compare the difference between two magnetic resonance imaging (MRI) techniques for visualizing arteries. The study hypothesizes that one method that relies upon imaging flowing blood in the pelvic and leg arteries will not be as accurate or efficient as injecting a safe imaging agent to change the appearance of the blood on the MRI. Both methods will be compared with Digital Subtraction Angiography (DSA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
- Subjects with symptoms of PAD
- Scheduled for DSA
Exclusion Criteria
- Critical leg ischemia manifested by ulcers, gangrene or leg amputation
- Laboratory evidence of iron overload, liver disease, pregnancy
- History of allergy to or recent exposure to radiocontrast, gadolinium chelates, or intravenous iron therapy
- Clinical concerns about co-morbidities, subject suitability
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 1 ferumoxytol Dose 1 versus non-contrast MRA 2 ferumoxytol Dose 2 versus non-contrast MRA 3 ferumoxytol Dose 3 versus non-contrast MRA
- Primary Outcome Measures
Name Time Method To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels 3 weeks
- Secondary Outcome Measures
Name Time Method To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels. 3 weeks