Clinical trial NCT00310609: Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral Branches
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 Disease of the Aortic Arch and Cerebral Branches Who Are Undergoing MRA of These Vessels With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as the Standard of Reference.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Abnormalities
Keywords: Structural abnormalities of the aortic arch and cerebral branches
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-04-04
Enrollment: 123
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 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.

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 disease of the aortic arch and cerebral branches
* 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 previous bilateral intervention (surgery, bypass) of the arteries of interest

Primary outcomes:
measure: Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader
timeFrame: Image creation after injection -evaluation at blind read
Secondary outcomes:
measure: Diagnostic confidence
timeFrame: At blinded and/or open label read of the images
measure: Visual assessment of stenosis
timeFrame: At blinded and/or open label read of the images
measure: Difference in degree of stenosis
timeFrame: At blinded and/or open label read of the images
measure: Other diagnostic findings
timeFrame: At blinded and/or open label read of the images
measure: Location and matching of stenosis
timeFrame: At blinded and/or open label read of the images
measure: Image quality
timeFrame: At blinded and/or open label read of the images
measure: Image evaluability and presence of artifacts
timeFrame: At blinded and/or open label read of the images
measure: Ability to visualize arterial segments
timeFrame: At blinded and/or open label read of the images
measure: Proportion of correctly categorized maximum stenosis per segment
timeFrame: At blinded and/or open label read of the images
measure: Number of evaluable segments
timeFrame: At blinded and/or open label read of the images
measure: Duration if 2D TOF and CE-MRA
timeFrame: At blinded and/or open label read of the images
measure: Patient management
timeFrame: From baseline to 24 hours follow-up
measure: Safety variables
timeFrame: From baseline to 24 hours follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: