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Whole Body Magnetic Resonance Angiography in Ischemic Patients

Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00538408
Enrollment
80
Registered
2007-10-02
Start date
2007-09-30
Completion date
2010-01-31
Last updated
2009-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Intermittent Claudication

Keywords

Magnetic resonance, whole body, angiography, vasovist, gadofosveset, dotarem, blood pool agent

Brief summary

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

Detailed 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.

Interventions

PROCEDUREWhole body magnetic resonance angiography (dotarem)
DEVICEWhole body magnetic resonance angiography (vasovist)

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
Copenhagen University Hospital at Herlev
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA.

Countries

Denmark

Contacts

Primary ContactYousef W. Nielsen, MD
yujwni01@heh.regionh.dk+45 44884391
Backup Contactjakob M Møller, M.Sc.
jaml@heh.regionh.dk+ +45 44883996

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026