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Whole Body Magnetic Resonance Angiography With Subsystolic Venous Compression

This study has been completed.
Sponsor:
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00560534
First received: November 16, 2007
Last updated: August 18, 2009
Last verified: August 2009
History of Changes
  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.

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof. Henrik Thomsen, Copenhagen University Hospital Herlev
ClinicalTrials.gov Identifier: NCT00560534     History of Changes
Other Study ID Numbers: WB-angio herlev 3
Study First Received: November 16, 2007
Last Updated: August 18, 2009
Health Authority: Denmark: National Board of Health

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

ClinicalTrials.gov processed this record on May 22, 2013