Whole Body Magnetic Resonance Angiography With Subsystolic Venous Compression

Atherosclerosis Clinical Trial

Official title:

Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia. Experience With Venous Compression.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560534
• Other study ID #: WB-angio herlev 3
• Status: Completed
• Phase: N/A
• First received: November 16, 2007
• Last updated: August 18, 2009
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: August 2009
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial Summary

To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using subsystolic venous compression of the thigh.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Intermittent Claudication

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Radiology, Herlev University Hospital	Herlev Copenhagen	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA		1 month	No