Skip to main content
OpenTrials
Completed

NCT Number: NCT00415805

Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Steno-occlusive Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bracco Imaging, S.p.A

Milan, 20134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known or suspected renovascular disease based on one of the following criteria:
  • severe hypertension
  • hypertension refractory to standard therapy
  • abrupt onset of moderate to severe hypertension at age < 35 years
  • normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension
  • unexplained by stable elevation of serum creatinine > 2Mg/dL
  • positive findings for stenosis from another imaging modality

Treatment and study plan

Multihance

Drug

0.5 Molar, single injection at 0.2 mL/kg

vasovist

Drug

0.25 molar single injection 0.03 ml/kg

Primary outcomes

  1. Sensitivity and specificity compared to DSA

    Time frame: post dose

Secondary outcomes

  1. accuracy and predictive values; inter-reader agreement for diagnostic performance

    Time frame: post dose

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study title

A Pilot, Open-label, Multicenter Intra-individual Comparison of Multihance and Vasovist for Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) of Renal Arteries

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Dec 25, 2006
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.