Whole Body Magnetic Resonance Angiography in Ischemic Patients

Sponsor

Copenhagen University Hospital at Herlev (Other)

Overall Status

Unknown status

CT.gov ID

NCT00538408

Collaborator

Rigshospitalet, Denmark (Other)

Enrollment

Location

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Intermittent Claudication	Procedure: Whole body magnetic resonance angiography (dotarem) Device: Whole body magnetic resonance angiography (vasovist)

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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Time Perspective:

Prospective

Official Title:

Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia

Study Start Date :

Sep 1, 2007

Anticipated Study Completion Date :

Jan 1, 2010

Outcome Measures

Primary Outcome Measures

Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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