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Garovic, VD; Achauer, MA; Kittner, T; Horak, D; Sheng, R; Stanson, AW.
Comparison of gadodiamide-enhanced MR angiography to intraarterial digital subtraction angiography for evaluation of renal artery stenosis: results of a phase III multicenter trial.
J MAGN RESON IMAGING. 2010; 31(2): 390-397.
Doi: 10.1002/jmri.22032
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- Co-authors Med Uni Graz
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Aschauer Manuela
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- Abstract:
- 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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Angiography, Digital Subtraction - methods
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Contrast Media -
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Female -
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Gadolinium DTPA - diagnostic use
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Humans -
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Image Enhancement - methods
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Internationality -
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Magnetic Resonance Angiography - methods
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Male -
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Models, Biological -
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Renal Artery Obstruction - diagnosis
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Reproducibility of Results -
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Sensitivity and Specificity -
- Find related publications in this database (Keywords)
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contrast-enhanced magnetic resonance angiography
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renal artery stenosis
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multicenter, controlled study
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gadodiamide administration