AtherosclerosisNCT00560534
Whole Body Magnetic Resonance Angiography With Subsystolic Venous Compression
An observational study of Atherosclerosis and Intermittent Claudication, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using subsystolic venous compression of the thigh. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Intermittent Claudication
- What is being tested?
- Whole body magnetic resonance angiography
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with peripheral arterial disease
Who may be able to join
- Symptomatic lower extremity ischemia (claudication, ischemic wounds)
- Referred to digital subtraction angiography (DSA)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Radiology, Herlev University Hospital
Herlev Copenhagen, Herlev, DK-2730
About this study
Official title: 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.
Read the 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.
- Conditions
- Atherosclerosis, Intermittent Claudication
- Being tested
- Whole body magnetic resonance angiography
- Keywords
- Magnetic resonance, whole body, angiography, venous compression, MRI
- Medical subject headings
- Atherosclerosis, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body magnetic resonance angiographyProcedure or surgery
Magnetic resonance angiography using a paramagnetic contrast agent.Venous compression performed with a blood-pressure cuff around both thighs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startJun 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Investigators
- Henrik S Thomsen, Prof. MD., Study chair, University Hospital at Herlev Copenhagen Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560534
- Sponsor's protocol ID
- WB-angio herlev 3
- Status last verified
- Aug 2009
- First submitted
- 16 Nov 2007
- Last updated
- 19 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia. Experience With Venous Compression.
- ClinicalTrials.gov ID
- NCT00560534
- Acronym / sponsor ID
- WB-angio herlev 3
- Conditions
- Atherosclerosis, Intermittent Claudication
- Keywords
- Magnetic resonance, whole body, angiography, venous compression, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jun 2008
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using subsystolic venous compression of the thigh.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral arterial disease
Key inclusion criteria (2 listed)
- Symptomatic lower extremity ischemia (claudication, ischemic wounds)
- Referred to digital subtraction angiography (DSA)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body magnetic resonance angiographyMagnetic resonance angiography using a paramagnetic contrast agent.Venous compression performed with a blood-pressure cuff around both thighs. | Procedure or surgery | – |
Primary outcome
Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik S Thomsen, Prof. MD. study chair
University Hospital at Herlev Copenhagen Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Intermittent Claudication, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2009.