Whole Body Magnetic Resonance Angiography in Ischemic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Copenhagen University Hospital at Herlev.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00538408
First received: October 1, 2007
Last updated: February 1, 2009
Last verified: February 2009

October 1, 2007
February 1, 2009
September 2007
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Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA.
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Complete list of historical versions of study NCT00538408 on ClinicalTrials.gov Archive Site
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Whole Body Magnetic Resonance Angiography in Ischemic Patients
Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia

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

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.

Observational
Time Perspective: Prospective
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  • Atherosclerosis
  • Intermittent Claudication
  • Procedure: Whole body magnetic resonance angiography (dotarem)
  • Device: Whole body magnetic resonance angiography (vasovist)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
January 2010
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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
Both
18 Years and older
No
Contact: Yousef W. Nielsen, MD +45 44884391 yujwni01@heh.regionh.dk
Contact: jakob M Møller, M.Sc. + +45 44883996 jaml@heh.regionh.dk
Denmark
 
NCT00538408
H-D-2007-0041
Yes
Yousef Nielsen, Herlev University Hospital
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Study Chair: Henrik S Thomsen, Prof. University Hospital at Herlev Copenhagen Denmark
Copenhagen University Hospital at Herlev
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP