AtherosclerosisNCT00834548
Whole-Body MRA at 3T - A Comparison Between Two Different Scan Protocols
An observational study of Atherosclerosis and Intermittent Claudication, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
To compare to different approaches in whole-body magnetic resonance angiography of patients suffering peripheral arterial disease. Our hypothesis is that use of a new protocol improves the diagnostic quality of the WB-MRA procedure. 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 (WB-MRA)
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2008to Aug 2008
- 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
Copenhagen University Hospital Herlev
Herlev Copenhagen, DK 2730
About this study
To compare to different approaches in whole-body magnetic resonance angiography of patients suffering peripheral arterial disease.
Our hypothesis is that use of a new protocol improves the diagnostic quality of the WB-MRA procedure.
Read the detailed description
Patients suffering peripheral arterial disease must undergo imaging procedures before endovascular or surgical procedures.
WB-MRA is an imaging procedure that can visualise the arterial system. WB-MRA can be performed in different manners. On option is to start the scan in the head region and continue down the body to the feet (standard protocol). Another option is to use a hybrid protocol that first examines the head and lower leg followed by examination of the pelvic and upper leg region.
A comparison between the standard and hybrid protocols has not been performed in a 3T high magnetic field system, therefore we will perform such a study.
- Conditions
- Atherosclerosis, Intermittent Claudication
- Being tested
- Whole body magnetic resonance angiography (WB-MRA)
- Keywords
- Magnetic resonance, whole body, angiography, hybrid protocol, 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 angiography (WB-MRA)Procedure or surgery
WB-MRA will be performed once in each patient.
| Study group | Role | What they receive |
|---|---|---|
| 1 | WB-MRA standard protocol Receives: Procedure: Whole body magnetic resonance angiography (WB-MRA) | |
| 2 | WB-MRA hybrid protocol Receives: Procedure: Whole body magnetic resonance angiography (WB-MRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic quality of WB-MRA
Secondary outcomes (2)
Signal to noise ratio
Contrast to noise ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJun 2008
- Study completionAug 2008
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Investigators
- Yousef W Nielsen, MD, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834548
- Sponsor's protocol ID
- Herlev WB-MRA 5
- Status last verified
- Feb 2009
- First submitted
- 26 Aug 2008
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Body MRA at 3T - A Comparison Between Two Different Scan Protocols
- ClinicalTrials.gov ID
- NCT00834548
- Acronym / sponsor ID
- Herlev WB-MRA 5
- Conditions
- Atherosclerosis, Intermittent Claudication
- Keywords
- Magnetic resonance, whole body, angiography, hybrid protocol, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Jun 2008
- Study completion
- Aug 2008 (actual)
- First posted
- 3 Feb 2009 (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 compare to different approaches in whole-body magnetic resonance angiography of patients suffering peripheral arterial disease.
Our hypothesis is that use of a new protocol improves the diagnostic quality of the WB-MRA procedure.
Detailed description
Patients suffering peripheral arterial disease must undergo imaging procedures before endovascular or surgical procedures.
WB-MRA is an imaging procedure that can visualise the arterial system. WB-MRA can be performed in different manners. On option is to start the scan in the head region and continue down the body to the feet (standard protocol). Another option is to use a hybrid protocol that first examines the head and lower leg followed by examination of the pelvic and upper leg region.
A comparison between the standard and hybrid protocols has not been performed in a 3T high magnetic field system, therefore we will perform such a study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Whole body magnetic resonance angiography (WB-MRA)WB-MRA standard protocol |
| 2 | – | Procedure: Whole body magnetic resonance angiography (WB-MRA)WB-MRA hybrid protocol |
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 angiography (WB-MRA)WB-MRA will be performed once in each patient. | Procedure or surgery | 1, 2 |
Primary outcome
Diagnostic quality of WB-MRA
2 secondary outcomes
Signal to noise ratio
Contrast to noise ratio
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 3 Feb 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.
Yousef W Nielsen, MD principal investigator
Copenhagen University Hospital at Herlev
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 3 Feb 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?
Diagnostic quality of WB-MRA. 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 3 Feb 2009.