Whole Body Magnetic Resonance Angiography in Ischemic Patients

• Conditions: Atherosclerosis; Intermittent Claudication

• Registration Number: NCT00538408
• Lead Sponsor: Copenhagen University Hospital at Herlev

Brief Summary

To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using two different magnetic resonance contrast agents.

Detailed Description

Atherosclerosis of the lower leg arteries is a common disease. Patients with this condition has symptoms of ischemia, for instance intermittent claudication (pain during exercise). Diagnosis of atherosclerosis in the legs is normally done with an interventional x-ray-based angiography (DSA- digital subtraction angiography). This is uncomfortable for the patient, and associated with risks of complications (bleeding, vascular damage, embolism).A novel approach to diagnosing atherosclerosis is the use of magnetic resonance angiography. A variant of this is the whole body magnetic resonance angiography(WB-MRA), that produce a picture of the arteries in almost the whole body (excluding the coronary arteries). WB-MRA has a number of advantages compared to DSA. It does not use ionizing radiation, is not invasive, uses a contrast medium with fewer side affects and finally gives a covers a great deal of the arteries in the body.

This study will compare WB-MRA with DSA in patients with symptoms of peripheral atherosclerosis in the lower legs. We will investigate 2 different contrast agents used for WB-MRA. The patients will be randomized to receive either the contrast medium Dotarem or the contrast medium Vasovist. In both groups we will compare the results of WB-MRA with DSA.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-01
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-01
• Last Update Posted: 2009-02-03
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Symptomatic lower extremity ischemia (claudication, ischemic wounds)
• Referred to digital subtraction angiography (DSA)

Exclusion Criteria

• Renal insufficiency (GFR < 30 ml/min)
• Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)
• Dementia
• Pregnancy/lactation
• Allergy to gadolinium based MRI contrast agents
• Acute disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA.

Trial Locations

Locations (1)

Department of Radiology, Herlev University Hospital; 🇩🇰 Herlev, Copenhagen, Denmark