A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide
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|ClinicalTrials.gov Identifier: NCT00209391|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : April 25, 2019
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body.
Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the renal artery vessels using MR.
The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction Angiography will be used as the standard of truth.
|Condition or disease||Intervention/treatment||Phase|
|Renal Artery Stenosis||Drug: Gadodiamide Injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||395 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Phase 3, Open-Label, Controlled Study Evaluating the Efficacy and Safety of 0.1 mmol/kg OMNISCAN (Gadodiamide Injection) in Magnetic Resonance Angiography (MRA) of the Renal Arteries|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||August 1, 2005|
|Actual Study Completion Date :||August 1, 2005|
Experimental: Gadodiamide Injection
All subjects will receive a single intravenous bolus injection via a power injector of Omniscan (Gadodiamide injection) at a dose of 0.1 mmol/kg.
Drug: Gadodiamide Injection
Other Name: Omniscan
- Subject level efficacy of CE-MRA in detecting stenosis (50% occlusion) of major renal arteries. IA-DSA is the truth standard. [ Time Frame: 72 hours ]
- Subject and vessel level efficacy comparison of CE-MRA and TOF-MRA in detecting stenosis, accessing arteries and diagnosis; Efficacy of CE-MRA and TOF-MAR combined; Clinical utility; Safety [ Time Frame: 72 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209391
|Amersham Buchler GmbH & Co. KG|
|Study Director:||Michael Karl, PhD||GE Healthcare|