Whole Body Magnetic Resonance Angiography in Ischemic Patients

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

Detailed Description
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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.

Official Title
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Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia

Conditions
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Atherosclerosis, Intermittent Claudication

Intervention / Treatment
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* Procedure: Whole body magnetic resonance angiography (dotarem)
* Device: Whole body magnetic resonance angiography (vasovist)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Whole body magnetic resonance angiography (dotarem)|nan|
|Device: Whole body magnetic resonance angiography (vasovist)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whole body, Magnetic resonance, angiography, vasovist, gadofosveset, dotarem, blood pool agent