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Whole Body Magnetic Resonance Angiography in Ischemic Patients
This study is currently recruiting participants.
Verified by Copenhagen University Hospital at Herlev, May 2008
Sponsors and Collaborators: Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Information provided by: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT00538408
  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)

Drug Information available for: Gadofosveset trisodium
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • 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: August 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538408

Contacts
Contact: Yousef W. Nielsen, MD +45 44884391 yujwni01@heh.regionh.dk
Contact: jakob M Møller, M.Sc. + +45 44883996 jaml@heh.regionh.dk

Locations
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            
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Investigators
Study Chair: Henrik S Thomsen, Prof. University Hospital at Herlev Copenhagen Denmark
  More Information

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

Keywords provided by Copenhagen University Hospital at Herlev:
Magnetic resonance
whole body
angiography
vasovist
gadofosveset
dotarem
blood pool agent

Study placed in the following topic categories:
Arterial Occlusive Diseases
Atherosclerosis
Signs and Symptoms
Vascular Diseases
Intermittent Claudication
Arteriosclerosis
Ischemia

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009