A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide

NCT ID: NCT00209391

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2005-08-01

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.

Conditions

Renal Artery Stenosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gadodiamide Injection

Intervention Type: DRUG

Interventions

Gadodiamide Injection

Intervention Type: DRUG

Other Intervention Names

Omniscan

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Karl, PhD

Role: STUDY_DIRECTOR

GE Healthcare

Locations

Amersham Buchler GmbH & Co. KG

Ismaning, , Germany

Countries

Germany

Other Identifiers

SOV301

Identifier Type: -

Identifier Source: org_study_id