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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00538408
Other study ID # H-D-2007-0041
Secondary ID
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
Est. primary completion date
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


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.
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