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Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries

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ClinicalTrials.gov Identifier: NCT00185276
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

September 10, 2005
September 16, 2005
December 30, 2014
March 2003
Not Provided
Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease [ Time Frame: Image creation after injection - evaluation at blind read ]
Percentage change in Bone Mineral Density at the lumbar spine
Complete list of historical versions of study NCT00185276 on ClinicalTrials.gov Archive Site
  • Diagnostic confidence [ Time Frame: At blinded or/and open label read of images ]
  • Visual assessment of stenosis [ Time Frame: At blinded or/and open label read of images ]
  • Difference in degree of stenosis [ Time Frame: At blinded or/and open label read of images ]
  • Other diagnostic findings [ Time Frame: At blinded or/and open label read of images ]
  • Image quality [ Time Frame: At blinded or/and open label read of images ]
  • Image evaluability and presence of artifacts [ Time Frame: At blinded or/and open label read of images ]
  • Ability to visualize arterial segments [ Time Frame: At blinded or/and open label read of images ]
  • Number of evaluable segments [ Time Frame: At blinded or/and open label read of images ]
  • Location and matching of stenosis [ Time Frame: At blinded or/and open label read of images ]
  • SI measurements [ Time Frame: At blinded or/and open label read of images ]
  • Patient management [ Time Frame: From baseline to 24 hours follow-up ]
  • Safety [ Time Frame: From baseline to 24 hours follow-up ]
  • - Percentage change in Bone Mineral Density at the hip
  • - Percentage change in biochemical markers of bone turnover
  • - Proportion of patients with hot flushes
  • - Women's Health Questionnaire
  • - Proportion of patients with an abnormal endometrial biopsy
  • - Arthralgia questionnaire
  • - Pharmacogenetic analysis
  • - Digital breast density analysis
Not Provided
Not Provided
 
Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries
Randomized, Multi-center Open Label Study of the Safety (Open-label) and Efficacy (Open-label & Blinded Reader) of Magnevist® Injection-enhanced Magnetic Resonance Arteriography (MRA) at Two Dose Levels and 2-dimensional-time-of-flight (2D-TOF) MRA in Patients Undergoing MRA of the Infrarenal Aorta and Peripheral Arteries With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as Standard of Reference
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 infrarenal aorta and peripheral arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Peripheral Vascular Disease
  • Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
    Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight
  • Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
    Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight
  • Experimental: Arm 1
    Intervention: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
  • Experimental: Arm 2
    Intervention: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
365
August 2004
Not Provided

Inclusion Criteria:

  • Has known or suspected peripheral vascular disease
  • 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 previously had stents placed bilaterally in the region to be imaged
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Denmark,   Estonia
 
NCT00185276
91208
306781
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP