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

Cardiovascular Abnormalities Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310609
• Other study ID #: 90941
• Secondary ID: 304630
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2006
• Last updated: December 29, 2014
• Start date: December 2003
• Est. completion date: October 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Ministry of HealthBrazil: Ministry of HealthCanada: Health CanadaChile: Ministry of HealthMexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Congenital Abnormalities

Intervention

Drug:
• Gadopentetate dimeglumine (Magnevist)
Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader		Image creation after injection -evaluation at blind read
Secondary	Diagnostic confidence		At blinded and/or open label read of the images
Secondary	Visual assessment of stenosis		At blinded and/or open label read of the images
Secondary	Difference in degree of stenosis		At blinded and/or open label read of the images
Secondary	Other diagnostic findings		At blinded and/or open label read of the images
Secondary	Location and matching of stenosis		At blinded and/or open label read of the images
Secondary	Image quality		At blinded and/or open label read of the images
Secondary	Image evaluability and presence of artifacts		At blinded and/or open label read of the images
Secondary	Ability to visualize arterial segments		At blinded and/or open label read of the images
Secondary	Proportion of correctly categorized maximum stenosis per segment		At blinded and/or open label read of the images
Secondary	Number of evaluable segments		At blinded and/or open label read of the images
Secondary	Duration if 2D TOF and CE-MRA		At blinded and/or open label read of the images
Secondary	Patient management		From baseline to 24 hours follow-up
Secondary	Safety variables		From baseline to 24 hours follow-up

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