Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral Branches

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00310609
First received: March 31, 2006
Last updated: October 10, 2013
Last verified: October 2013
  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.


Condition Intervention Phase
Cardiovascular Abnormalities
Drug: Gadopentetate dimeglumine (Magnevist)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader [ Time Frame: Image creation after injection -evaluation at blind read ]

Secondary Outcome Measures:
  • Diagnostic confidence [ Time Frame: At blinded and/or open label read of the images ]
  • Visual assessment of stenosis [ Time Frame: At blinded and/or open label read of the images ]
  • Difference in degree of stenosis [ Time Frame: At blinded and/or open label read of the images ]
  • Other diagnostic findings [ Time Frame: At blinded and/or open label read of the images ]
  • Location and matching of stenosis [ Time Frame: At blinded and/or open label read of the images ]
  • Image quality [ Time Frame: At blinded and/or open label read of the images ]
  • Image evaluability and presence of artifacts [ Time Frame: At blinded and/or open label read of the images ]
  • Ability to visualize arterial segments [ Time Frame: At blinded and/or open label read of the images ]
  • Proportion of correctly categorized maximum stenosis per segment [ Time Frame: At blinded and/or open label read of the images ]
  • Number of evaluable segments [ Time Frame: At blinded and/or open label read of the images ]
  • Duration if 2D TOF and CE-MRA [ Time Frame: At blinded and/or open label read of the images ]
  • Patient management [ Time Frame: From baseline to 24 hours follow-up ]
  • Safety variables [ Time Frame: From baseline to 24 hours follow-up ]

Enrollment: 129
Study Start Date: December 2003
Study Completion Date: October 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gadopentetate dimeglumine (Magnevist)
Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310609

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00310609     History of Changes
Other Study ID Numbers: 90941, 304630
Study First Received: March 31, 2006
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Canada: Health Canada
Chile: Ministry of Health
Mexico: Ministry of Health

Keywords provided by Bayer:
Structural abnormalities of the aortic arch and cerebral branches

Additional relevant MeSH terms:
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014