- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00560534
Whole Body Magnetic Resonance Angiography With Subsystolic Venous Compression
August 18, 2009 updated by: Copenhagen University Hospital at Herlev
Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia. Experience With Venous Compression.
To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using subsystolic venous compression of the thigh.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Herlev
-
Herlev Copenhagen, Herlev, Denmark, DK-2730
- Department of Radiology, Herlev University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with peripheral arterial disease
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Henrik S Thomsen, Prof. MD., University Hospital at Herlev Copenhagen Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
November 16, 2007
First Submitted That Met QC Criteria
November 16, 2007
First Posted (Estimate)
November 19, 2007
Study Record Updates
Last Update Posted (Estimate)
August 19, 2009
Last Update Submitted That Met QC Criteria
August 18, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WB-angio herlev 3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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