Clinical trial NCT00310557: Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries
Official title: Multicenter, Open-label Study of the Safety (Open-label) and Efficacy (Open-label and Blinded Reader) of a Single Administration of Approximately 0.1 mmol/kg of Magnevist® Injection-enhanced Magnetic Resonance Arteriography (MRA) and 2-dimensional-time-of-flight (2D-TOF) MRA in Patients With Known or Suspected Renal Artery Disease Undergoing MRA of the Renal Arteries With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as the Standard of Reference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Artery Stenosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-04-04
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: - Has known or suspected renal artery disease - Is scheduled for X-ray angiography Exclusion Criteria: - Has any contraindication to magnetic resonance imaging - Is scheduled for any procedure before the X-ray angiography - Had previously had stents placed bilaterally in the region to be imaged

Primary outcomes:
measure: Accuracy, sensitivity and specificity based on quantitative assessment of stenosis
timeFrame: Image creation after injection - evaluation at blind read
Secondary outcomes:
measure: Diagnostic confidence
timeFrame: At blinded and/or open label read of images
measure: Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses
timeFrame: At blinded and/or open label read of images
measure: Difference in degree of stenosis
timeFrame: At blinded and/or open label read of images
measure: Other diagnostic findings
timeFrame: At blinded and/or open label read of images
measure: Localisation matching of maximum stenosis
timeFrame: At blinded and/or open label read of images
measure: Image quality
timeFrame: At blinded and/or open label read of images
measure: Image evaluability and presence of artifacts
timeFrame: At blinded and/or open label read of images
measure: Proportions of correctly categorised arteries with regard to maximum stenosis
timeFrame: At blinded and/or open label read of images
measure: Number of evaluable arteries
timeFrame: At blinded and/or open label read of images
measure: Patient management
timeFrame: From baseline to 24 hours follow-up
measure: Safety
timeFrame: From baseline to 24 hours follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: