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Whole Body Magnetic Resonance Angiography With Subsystolic Venous Compression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560534
First Posted: November 19, 2007
Last Update Posted: August 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Copenhagen University Hospital at Herlev
  Purpose
To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using subsystolic venous compression of the thigh.

Condition Intervention
Atherosclerosis Intermittent Claudication Procedure: Whole body magnetic resonance angiography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia. Experience With Venous Compression.

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 [ Time Frame: 1 month ]

Estimated Enrollment: 36
Study Start Date: June 2008
Study Completion Date: March 2009
Intervention Details:
    Procedure: Whole body magnetic resonance angiography
    Magnetic resonance angiography using a paramagnetic contrast agent.Venous compression performed with a blood-pressure cuff around both thighs.
Detailed Description:
WB-MRA is an examination that can evaluate the arteries from head to feet. Timing of the injected bolus of contrast medium can be difficult, especially in the legs. As the result of the WB-MRA depends on the contrast medium only being in the arteries at the time of examination, the use of venous compression is a possible way of overcoming the problem of early venous filling, that can hamper the diagnostic value of the examination. Venous compression is performed with a blod pressure cuff around the thighs. It is inflated to subsystolic pressure (45 mm Hg). This elevated pressure leads to filling of the lower leg arteries and late venous filling.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with peripheral 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
  Contacts and Locations
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): NCT00560534


Locations
Denmark
Department of Radiology, Herlev University Hospital
Herlev Copenhagen, Herlev, Denmark, DK-2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Study Chair: Henrik S Thomsen, Prof. MD. University Hospital at Herlev Copenhagen Denmark
  More Information

Responsible Party: Prof. Henrik Thomsen, Copenhagen University Hospital Herlev
ClinicalTrials.gov Identifier: NCT00560534     History of Changes
Other Study ID Numbers: WB-angio herlev 3
First Submitted: November 16, 2007
First Posted: November 19, 2007
Last Update Posted: August 19, 2009
Last Verified: August 2009

Keywords provided by Copenhagen University Hospital at Herlev:
Magnetic resonance
whole body
angiography
venous compression
MRI

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