Clinical trial NCT00209391: A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Artery Stenosis
Keywords: Renal Artery Stenosis
Occlusion
Diagnostic Imaging
Omniscan
Magnetic Resonance Angiography
Contrast Media
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: GEHC has decided not to provide this detail.

Eligibility criteria: Inclusion Criteria:

* Study Subjects must be adults with confirmed or suspected Renal Artery stenosis.
* The subject must have been referred for Digital Subtraction Angiography.

Exclusion Criteria:

* The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR contrast media including, but not restricted to, the investigational product.
* The subject is lactating.
* The subject is pregnant as defined by a serum or urine β-HCG pregnancy test obtained within 24 hours before investigational product administration.
* The subject has received or is scheduled to receive MRI contrast medium within 24 h prior to or less than 24 hours after the investigational product administration.
* The subject has received or is scheduled to receive X-ray contrast medium within 7 days prior to or less than 24 hours after administration of investigational product.
* The subject has received an investigational product within 30 days prior to or will receive an investigational product less than 24 hours after investigational product administration.
* The subject has an active, serious, life-threatening disease with a life expectancy of less than 6 months.
* The subject has had a percutaneous transluminal angioplasty (PTA) in the renal region performed within 4 weeks prior to investigational product administration.
* The subject has a stent in the renal arteries.
* The subject has had a kidney transplantation.
* The subject has a serum creatinine value of \>3.5 mg/dL (309.4 µmol/L).
* The subject has previously been included in this study.
* The subject has a contra-indication for MRI according to accepted clinical guidelines.

Primary outcomes:
measure: Subject level efficacy of CE-MRA in detecting stenosis (50% occlusion) of major renal arteries. IA-DSA is the truth standard.
timeFrame: 72 hours
Secondary outcomes:
measure: 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
timeFrame: 72 hours
Other outcomes:
Locations:
city: Ismaning
country: Germany
facility: Amersham Buchler GmbH & Co. KG
Study officials:
affiliation: GE Healthcare
name: Michael Karl, PhD
role: STUDY_DIRECTOR
References: