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

This study has suspended participant recruitment.
(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.)
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00554073
First received: November 5, 2007
Last updated: August 18, 2009
Last verified: August 2009

November 5, 2007
August 18, 2009
May 2008
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Complete list of historical versions of study NCT00554073 on ClinicalTrials.gov Archive Site
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Whole Body Magnetic Resonance Angiography in Ischemic Patients at 1.5 and 3T
Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia: A Comparison Between 1.5 and 3T MRI-systems

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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients with intermittent claudication (pheripheral arterial disease)

  • Atherosclerosis
  • Intermittent Claudication
  • MRI
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
12
August 2009
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00554073
WB-angio herlev 2
Yes
Yousef Nielsen, Department of Radiology, Copenhagen University Hospital Herlev
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Study Chair: Henrik S Thomsen, Prof. MD. University Hospital at Herlev Copenhagen Denmark
Copenhagen University Hospital at Herlev
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP