check_circleStudy Completed
Cardiovascular Abnormalities
Bayer Identifier:
90941
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Magnevist® Injection enhanced MRA compared to non contrast MRA for the detection of structural abnormalities of the aortic arch and cerebral branches
Trial purpose
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 aortic arch and cerebral branches. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
123Trial Dates
December 2003 - October 2004Phase
Phase 3Could I Receive a placebo
NoProducts
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)Accepts Healthy Volunteer
NoPrimary Outcome
- Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded readerdate_rangeTime Frame:Image creation after injection -evaluation at blind readenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Diagnostic confidencedate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Visual assessment of stenosisdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Difference in degree of stenosisdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Other diagnostic findingsdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Location and matching of stenosisdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Image qualitydate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Image evaluability and presence of artifactsdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Ability to visualize arterial segmentsdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Proportion of correctly categorized maximum stenosis per segmentdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Number of evaluable segmentsdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Duration if 2D TOF and CE-MRAdate_rangeTime Frame:At blinded and/or open label read of the imagesenhanced_encryptionNoneSafety Issue:
- Patient managementdate_rangeTime Frame:From baseline to 24 hours follow-upenhanced_encryptionNoneSafety Issue:
- Safety variablesdate_rangeTime Frame:From baseline to 24 hours follow-upenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1