| Comparison of gadodiamide-enhanced MR angiography to intraarterial digital subtraction angiography for evaluation of renal artery stenosis: results of a phase III multicenter trial. | |
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MedLine Citation:
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PMID: 20099352 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: To evaluate the efficacy and safety of 0.1 mmol/kg gadodiamide administration for contrast-enhanced magnetic resonance angiography (MRA) in detecting hemodynamically relevant renal artery stenosis (RAS) when compared with intraarterial digital subtraction angiography (IA-DSA) as the gold standard. MATERIALS AND METHODS: In a multicenter, controlled study, 395 patients with suspected or known RAS were included. Three independent readers evaluated the MRA images. Two readers evaluated the IA-DSA images and subsequently achieved consensus. The sensitivities and specificities of gadodiamide-enhanced MRA were analyzed at the per-patient and per-vessel levels (exact 1-sided binomial test at alpha = 0.025 with 95% confidence interval). RESULTS: A total of 335 patients who had available standard of truth and MRA tests were included in the all-subjects efficacy population: 55.5% (186/335) men and 44.5% women with a mean age of 63 +/- 13 years (range 17-85 years). The sensitivities and specificities ranged from 81% to 86% for all independent readers at the per-patient analysis based on subjects with the diagnostic images. Similar results were achieved with per-vessel level analysis. Fewer than 1% of patients had adverse event associated with gadodiamide administration. There were no cases of nephrogenic systemic fibrosis (NSF) reported. CONCLUSION: Gadodiamide administration at the labeled dose of 0.1 mmol/kg for contrast-enhanced MRA achieved equivalent results compared to IA-DSA in evaluation of RAS and was well tolerated. |
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Authors:
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Vesna D Garovic; Manuela A Achauer; Thomas Kittner; David Hor?k; Rubin Sheng; Anthony W Stanson |
Publication Detail:
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Type: Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of magnetic resonance imaging : JMRI Volume: 31 ISSN: 1522-2586 ISO Abbreviation: J Magn Reson Imaging Publication Date: 2010 Feb |
Date Detail:
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Created Date: 2010-01-29 Completed Date: 2010-04-15 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9105850 Medline TA: J Magn Reson Imaging Country: United States |
Other Details:
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Languages: eng Pagination: 390-7 Citation Subset: IM |
Affiliation:
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Department of Medicine, Mayo Clinic, Rochester, Minnesota, USA. garovic.vesna@mayo.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Angiography, Digital Subtraction
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methods* Contrast Media Female Gadolinium DTPA / diagnostic use* Humans Image Enhancement / methods* Internationality Magnetic Resonance Angiography / methods* Male Models, Biological Renal Artery Obstruction / diagnosis* Reproducibility of Results Sensitivity and Specificity |
| Chemical | |
Reg. No./Substance:
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0/Contrast Media; 122795-43-1/gadodiamide; 80529-93-7/Gadolinium DTPA |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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