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Whole Body Magnetic Resonance Angiography in Ischemic Patients at 1.5 and 3T

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ClinicalTrials.gov Identifier: NCT00554073
Recruitment Status : Suspended (It was not possible to perform 2 MRI studies in each patient due to practical problems. The study was not suspended due to safety issues.)
First Posted : November 6, 2007
Last Update Posted : August 19, 2009
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by:
Copenhagen University Hospital at Herlev

Brief Summary:
To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using two different magnetic resonance scanners at a field strength of 1.5 and 3T. The hypothesis is that use of the 3T system gives superior signals from the investigated arteries, when compared with 1.5T.

Condition or disease
Atherosclerosis Intermittent Claudication MRI

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.

All the patients will undergo arterial first pass whole-body MRA in the 3T-system. This will be followed by a WB-MRA steady state examination which can be performed because we use the intravascular contrast medium Vasovist, that has a prolonged intravascular life. The steady state examination will be performed in both the 3T and the 1.5T MR-system. Half the patients will have the steady state examination performed first in the 3T and then the 1.5T-system. The other half will go to the 1.5T-system first and then return to the 3T-system.


Study Type : Observational
Estimated Enrollment : 12 participants
Time Perspective: Prospective
Official Title: Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia: A Comparison Between 1.5 and 3T MRI-systems
Study Start Date : May 2008
Estimated Study Completion Date : August 2009




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with intermittent claudication (pheripheral arterial disease)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554073


Locations
Denmark
Department of Radiology, Herlev University Hospital
Herlev Copenhagen, Herlev, Denmark, DK2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Investigators
Study Chair: Henrik S Thomsen, Prof. MD. University Hospital at Herlev Copenhagen Denmark

Responsible Party: Yousef Nielsen, Department of Radiology, Copenhagen University Hospital Herlev
ClinicalTrials.gov Identifier: NCT00554073     History of Changes
Other Study ID Numbers: WB-angio herlev 2
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: August 19, 2009
Last Verified: August 2009

Keywords provided by Copenhagen University Hospital at Herlev:
Magnetic resonance
whole body
angiography
vasovist
gadofosveset
blood pool agent
3T
1.5T
Field strength

Additional relevant MeSH terms:
Atherosclerosis
Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms