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Sponsors and Collaborators: |
Copenhagen University Hospital at Herlev Rigshospitalet, Denmark |
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Information provided by: | Copenhagen University Hospital at Herlev |
ClinicalTrials.gov Identifier: | NCT00538408 |
To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using two different magnetic resonance contrast agents.
Condition | Intervention |
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Atherosclerosis Intermittent Claudication |
Procedure: Whole body magnetic resonance angiography (dotarem) Device: Whole body magnetic resonance angiography (vasovist) |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia |
Estimated Enrollment: | 80 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | August 2009 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yousef W. Nielsen, MD | +45 44884391 | yujwni01@heh.regionh.dk |
Contact: jakob M Møller, M.Sc. | + +45 44883996 | jaml@heh.regionh.dk |
Denmark | |
Department of Radiology, Herlev University Hospital | Recruiting |
Herlev, Copenhagen, Denmark, DK-2730 | |
Contact: Yousef W. Nielsen, MD. +45 4488 4391 yujwni01@heh.regionh.dk | |
Principal Investigator: Yousef W. Nielsen, MD |
Study Chair: | Henrik S Thomsen, Prof. | University Hospital at Herlev Copenhagen Denmark |
Responsible Party: | Herlev University Hospital ( Yousef Nielsen ) |
Study ID Numbers: | H-D-2007-0041 |
Study First Received: | October 1, 2007 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00538408 |
Health Authority: | Denmark: The National Board of Health |
Magnetic resonance whole body angiography vasovist |
gadofosveset dotarem blood pool agent |
Arterial Occlusive Diseases Atherosclerosis Signs and Symptoms Vascular Diseases |
Intermittent Claudication Arteriosclerosis Ischemia |
Cardiovascular Diseases |