Whole Body Magnetic Resonance Angiography in Ischemic Patients

Atherosclerosis Clinical Trial

Official title:

Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00538408
• Other study ID #: H-D-2007-0041
• Status: Recruiting
• Phase: N/A
• First received: October 1, 2007
• Last updated: February 1, 2009
• Start date: September 2007
• Est. completion date: January 2010

Study information

• Verified date: February 2009
• Source: Copenhagen University Hospital at Herlev
• Contact: Yousef W. Nielsen, MD
• Phone: +45 44884391
• Email: yujwni01[@]heh.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The National Board of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Intermittent Claudication

Intervention

Procedure:
• Whole body magnetic resonance angiography (dotarem)

Device:
• Whole body magnetic resonance angiography (vasovist)

Locations

Country	Name	City	State
Denmark	Department of Radiology, Herlev University Hospital	Herlev, Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA.