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The purpose of this study is to compare magnetic resonance angiography (MRA) using gadoterate meglumine to clinically obtained MRA using gadobutrol. The specific aims are to show:
In this study, we will assess the image quality and accuracy of MRA studies acquired using these two contrast agents. In the cases where Digital Subtraction Angiography (DSA) or CT angiography images are available, the results of the study using both contrast agents will be compared to the DSA or CTA findings. All MRA images will be assessed independently by two readers. The readers will be blinded to the clinical symptoms, contrast agent and DSA/CTA results. A five-level system rating for image quality of each arterial segment will be used (1 = non-diagnostic images, 2 = poor image quality, significant blurring/artefacts, diagnosis suspected but not established, 3 = fair quality with established diagnosis, 4=good quality with definite diagnosis, minimal blurring/artefacts, 5 = sharply defined borders, excellent quality image information). Vascular lesions will also be graded on a 1-5 scale. Vessel segment stenoses will be graded using a five-point grading scale as follows: (1) normal; (2) mild (<50% diameter stenosis); (3) moderate (50% to 74%), severe (75% to 99%); and (5) total occlusion.
Grades 1 and 2 will be considered insignificant, while grades 3 to 5 will be interpreted as significant for diagnostic accuracy testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2x dose of Dotarem | qualifying MRA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dotarem | Diagnostic Test | (Dotarem) (0.4 ml/kg (0.2 mmol/kg)) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of MRA image quality | assess the image quality of MRA studies acquired using these two contrast | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of MRA accuracy | Assess the accuracy of MRA studies acquired using these two contrast | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
• Allergy to gadolinium-containing contrast media
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qualifying MRA
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| Name | Affiliation | Role |
|---|---|---|
| James Carr | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yasmeen Khan | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12732691 | Background | Eng J. Sample size estimation: how many individuals should be studied? Radiology. 2003 May;227(2):309-13. doi: 10.1148/radiol.2272012051. | |
| 19116027 | Result | Seeger A, Kramer U, Fenchel M, Grimm F, Bretschneider C, Doring J, Klumpp B, Tepe G, Rittig K, Seidensticker PR, Claussen CD, Miller S. Comparison between a linear versus a macrocyclic contrast agent for whole body MR angiography in a clinical routine setting. J Cardiovasc Magn Reson. 2008 Dec 30;10(1):63. doi: 10.1186/1532-429X-10-63. |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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