check_circleStudy Completed

Cardiovascular Abnormalities

Bayer Identifier:

90941

ClinicalTrials.gov Identifier:

NCT00310609

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

Both

Age

18 Years
  • - Has known or suspected disease of the aortic arch and cerebral branches
    - Is scheduled for X-ray angiography
  • - 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

Trial summary

Enrollment Goal
123
Trial Dates
December 2003 - October 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteer
No

Primary Outcome

  • Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader
    date_rangeTime Frame:
    Image creation after injection -evaluation at blind read
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Diagnostic confidence
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Visual assessment of stenosis
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Difference in degree of stenosis
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Other diagnostic findings
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Location and matching of stenosis
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Image quality
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Image evaluability and presence of artifacts
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Ability to visualize arterial segments
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Proportion of correctly categorized maximum stenosis per segment
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Number of evaluable segments
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Duration if 2D TOF and CE-MRA
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Patient management
    date_rangeTime Frame:
    From baseline to 24 hours follow-up
    enhanced_encryption
    Safety Issue:
    None
  • Safety variables
    date_rangeTime Frame:
    From baseline to 24 hours follow-up
    enhanced_encryption
    Safety Issue:
    None

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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