The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the renal arteries. The results will be compared to the results of MRI taken without Magnevist and with the results of your X-ray angiography.
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
116
Approximately 0.1mmol/kg body weight, single intravenous administration on the study day
Accuracy, sensitivity and specificity based on quantitative assessment of stenosis
Time frame: Image creation after injection - evaluation at blind read
Diagnostic confidence
Time frame: At blinded and/or open label read of images
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses
Time frame: At blinded and/or open label read of images
Difference in degree of stenosis
Time frame: At blinded and/or open label read of images
Other diagnostic findings
Time frame: At blinded and/or open label read of images
Localisation matching of maximum stenosis
Time frame: At blinded and/or open label read of images
Image quality
Time frame: At blinded and/or open label read of images
Image evaluability and presence of artifacts
Time frame: At blinded and/or open label read of images
Proportions of correctly categorised arteries with regard to maximum stenosis
Time frame: At blinded and/or open label read of images
Number of evaluable arteries
Time frame: At blinded and/or open label read of images
Patient management
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From baseline to 24 hours follow-up
Safety
Time frame: From baseline to 24 hours follow-up