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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00310609

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 III

Drug Information available for: Gadolinium DTPA

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

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
Arm 1: Experimental	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:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head ( Bayer Healthcare Pharmaceuticals Inc. )
Study ID Numbers:	90941, 304630
Study First Received:	March 31, 2006
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00310609 History of Changes
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

Study placed in the following topic categories:

Cardiovascular Abnormalities
Congenital Abnormalities

Additional relevant MeSH terms:

Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 07, 2009