Trial record 14 of 30 for:    Open Studies | "Intermittent Claudication"

Whole Body Magnetic Resonance Angiography in Ischemic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Copenhagen University Hospital at Herlev.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00538408
First received: October 1, 2007
Last updated: February 1, 2009
Last verified: February 2009
  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

Resource links provided by NLM:


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: January 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Arteriosclerosis
Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014