Whole Body Magnetic Resonance Angiography in Ischemic Patients at 1.5 and 3T

NCT ID: NCT00554073

Last Updated: 2009-08-19

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-08-31

Brief Summary

To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using two different magnetic resonance scanners at a field strength of 1.5 and 3T. The hypothesis is that use of the 3T system gives superior signals from the investigated arteries, when compared with 1.5T.

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.

All the patients will undergo arterial first pass whole-body MRA in the 3T-system. This will be followed by a WB-MRA steady state examination which can be performed because we use the intravascular contrast medium Vasovist, that has a prolonged intravascular life. The steady state examination will be performed in both the 3T and the 1.5T MR-system. Half the patients will have the steady state examination performed first in the 3T and then the 1.5T-system. The other half will go to the 1.5T-system first and then return to the 3T-system.

Conditions

Atherosclerosis; Intermittent Claudication; MRI

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

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

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: lead

Responsible Party

Department of Radiology, Copenhagen University Hospital Herlev

Principal Investigators

Henrik S Thomsen, Prof. MD.

Role: STUDY_CHAIR

University Hospital at Herlev Copenhagen Denmark

Locations

Department of Radiology, Herlev University Hospital

Herlev Copenhagen, Herlev, Denmark

Countries

Denmark

Other Identifiers

WB-angio herlev 2

Identifier Type: -

Identifier Source: org_study_id