Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Add like
Add dislike
Add to saved papers

Comparison of gadodiamide-enhanced MR angiography to intraarterial digital subtraction angiography for evaluation of renal artery stenosis: results of a phase III multicenter trial.

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.

Full text links

We have located links that may give you full text access.
Can't access the paper?
Try logging in through your university/institutional subscription. For a smoother one-click institutional access experience, please use our mobile app.

Related Resources

For the best experience, use the Read mobile app

Mobile app image

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.

By using this service, you agree to our terms of use and privacy policy.

Your Privacy Choices Toggle icon

You can now claim free CME credits for this literature searchClaim now

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app