Whole Body Magnetic Resonance Angiography in Ischemic Patients
Recruitment status was Recruiting
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Purpose
To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using two different magnetic resonance contrast agents.
| Condition | Intervention |
|---|---|
|
Atherosclerosis Intermittent Claudication |
Procedure: Whole body magnetic resonance angiography (dotarem) Device: Whole body magnetic resonance angiography (vasovist) |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia |
- Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA.
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | January 2010 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Yousef Nielsen, Herlev University Hospital |
| ClinicalTrials.gov Identifier: | NCT00538408 History of Changes |
| Other Study ID Numbers: | H-D-2007-0041 |
| Study First Received: | October 1, 2007 |
| Last Updated: | February 1, 2009 |
| Health Authority: | Denmark: The National Board of Health |
Keywords provided by Copenhagen University Hospital at Herlev:
|
Magnetic resonance whole body angiography vasovist |
gadofosveset dotarem blood pool agent |
Additional relevant MeSH terms:
|
Atherosclerosis Intermittent Claudication Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013