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| ID | Type | Description | Link |
|---|---|---|---|
| 304630 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadopentetate dimeglumine (Magnevist) | Drug | Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader | Image creation after injection -evaluation at blind read |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic confidence | At blinded and/or open label read of the images | |
| Visual assessment of stenosis | At blinded and/or open label read of the images | |
| Difference in degree of stenosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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| At blinded and/or open label read of the images |
| Other diagnostic findings | At blinded and/or open label read of the images |
| Location and matching of stenosis | At blinded and/or open label read of the images |
| Image quality | At blinded and/or open label read of the images |
| Image evaluability and presence of artifacts | At blinded and/or open label read of the images |
| Ability to visualize arterial segments | At blinded and/or open label read of the images |
| Proportion of correctly categorized maximum stenosis per segment | At blinded and/or open label read of the images |
| Number of evaluable segments | At blinded and/or open label read of the images |
| Duration if 2D TOF and CE-MRA | At blinded and/or open label read of the images |
| Patient management | From baseline to 24 hours follow-up |
| Safety variables | From baseline to 24 hours follow-up |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
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