Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries
Primary Purpose
Renal Artery Stenosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gadopentetate dimeglumine (Magnevist)
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Artery Stenosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Accuracy, sensitivity and specificity based on quantitative assessment of stenosis
Secondary Outcome Measures
Diagnostic confidence
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses
Difference in degree of stenosis
Other diagnostic findings
Localisation matching of maximum stenosis
Image quality
Image evaluability and presence of artifacts
Proportions of correctly categorised arteries with regard to maximum stenosis
Number of evaluable arteries
Patient management
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00310557
Brief Title
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
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Stenosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gadopentetate dimeglumine (Magnevist)
Intervention Description
Approximately 0.1mmol/kg body weight, single intravenous administration on the study day
Primary Outcome Measure Information:
Title
Accuracy, sensitivity and specificity based on quantitative assessment of stenosis
Time Frame
Image creation after injection - evaluation at blind read
Secondary Outcome Measure Information:
Title
Diagnostic confidence
Time Frame
At blinded and/or open label read of images
Title
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses
Time Frame
At blinded and/or open label read of images
Title
Difference in degree of stenosis
Time Frame
At blinded and/or open label read of images
Title
Other diagnostic findings
Time Frame
At blinded and/or open label read of images
Title
Localisation matching of maximum stenosis
Time Frame
At blinded and/or open label read of images
Title
Image quality
Time Frame
At blinded and/or open label read of images
Title
Image evaluability and presence of artifacts
Time Frame
At blinded and/or open label read of images
Title
Proportions of correctly categorised arteries with regard to maximum stenosis
Time Frame
At blinded and/or open label read of images
Title
Number of evaluable arteries
Time Frame
At blinded and/or open label read of images
Title
Patient management
Time Frame
From baseline to 24 hours follow-up
Title
Safety
Time Frame
From baseline to 24 hours follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries
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