| Renal artery stenosis evaluation: diagnostic performance of gadobenate dimeglumine-enhanced MR angiography--comparison with DSA. | |
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MedLine Citation:
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PMID: 18372471 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: To prospectively determine diagnostic performance and safety of contrast material-enhanced (CE) magnetic resonance (MR) angiography with 0.1 mmol per kilogram of body weight gadobenate dimeglumine for depiction of significant steno-occlusive disease (> or =51% stenosis) of renal arteries, with digital subtraction angiography (DSA) as reference standard. MATERIALS AND METHODS: This multicenter study was approved by local institutional review boards; all patients provided written informed consent. Patient enrollment and examination at centers in the United States complied with HIPAA. Two hundred ninety-three patients (154 men, 139 women; mean age, 61.0 years) with severe hypertension (82.2%), progressive renal failure (11.3%), and suspected renal artery stenosis (6.5%) underwent CE MR angiography with three-dimensional spoiled gradient-echo sequences after administration of 0.1 mmol/kg gadobenate dimeglumine at 2 mL/sec. Anteroposterior and oblique DSA was performed in 268 (91.5%) patients. Three independent blinded reviewers evaluated CE MR angiographic images. Sensitivity, specificity, and accuracy of CE MR angiography for detection of significant steno-occlusive disease (> or =51% vessel lumen narrowing) were determined at segment (main renal artery) and patient levels. Positive and negative predictive values and positive and negative likelihood ratios were determined. Interobserver agreement was analyzed with generalized kappa statistics. A safety evaluation (clinical examination, electrocardiogram, blood and urine analysis, monitoring for adverse events) was performed. RESULTS: Of 268 patients, 178 who were evaluated with MR angiography and DSA had significant steno-occlusive disease of renal arteries at DSA. Sensitivity, specificity, and accuracy of CE MR angiography for detection of 51% or greater stenosis or occlusion were 60.1%-84.1%, 89.4%-94.7%, and 80.4%-86.9%, respectively, at segment level. Similar values were obtained for predictive values and for patient-level analyses. Few CE MR angiographic examinations (1.9%-2.8%) were technically inadequate. Interobserver agreement for detection of significant steno-occlusive disease was good (79.9% agreement; kappa = 0.69). No safety concerns were noted. CONCLUSION: CE MR angiography performed with 0.1 mmol/kg gadobenate dimeglumine, compared with DSA, is safe and provides good sensitivity, specificity, and accuracy for detection of significant renal artery steno-occlusive disease. |
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Authors:
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Gilles Soulez; Mieczyslaw Pasowicz; Giorgio Benea; Luigi Grazioli; Juan Pablo Niedmann; Marek Konopka; Philippe C Douek; Giovanni Morana; Fritz K W Schaefer; Angelo Vanzulli; David A Bluemke; Jeffrey H Maki; Martin R Prince; Günther Schneider; Claudio Ballarati; Richard Coulden; Martin N Wasser; Thomas R McCauley; Miles A Kirchin; Gianpaolo Pirovano |
Publication Detail:
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Type: Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study Date: 2008-02-07 |
Journal Detail:
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Title: Radiology Volume: 247 ISSN: 1527-1315 ISO Abbreviation: Radiology Publication Date: 2008 Apr |
Date Detail:
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Created Date: 2008-03-28 Completed Date: 2008-04-25 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0401260 Medline TA: Radiology Country: United States |
Other Details:
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Languages: eng Pagination: 273-85 Citation Subset: AIM; IM |
Affiliation:
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Department of Radiology, Centre Hospitalier de l'Université de Montréal, University of Montreal, 1560 Sherbrooke East, Montreal, QC, Canada H2V 2Z2. gilles.soulez.chum@ssss.gouv.qc.ca |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Aged, 80 and over Angiography, Digital Subtraction* Contrast Media* Female Humans Magnetic Resonance Angiography* Male Meglumine / analogs & derivatives*, diagnostic use Middle Aged Organometallic Compounds / diagnostic use* Predictive Value of Tests Renal Artery / pathology, radiography Renal Artery Obstruction / diagnosis*, radiography Sensitivity and Specificity |
| Chemical | |
Reg. No./Substance:
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0/Contrast Media; 0/Organometallic Compounds; 113662-23-0/gadobenic acid; 6284-40-8/Meglumine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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