Aortic AneurysmPhase 2/3NCT00794092
Magnetic Resonance Imaging of Aortic Aneurysm Instability
A Phase 2/3 study testing Sinerem administration in people with Aortic Aneurysm, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Abdominal aortic aneurysm (AAA) is a progressive enlargement of the aorta, the largest blood vessel in the body. It is at risk of bursting when it is usually fatal. Currently the risk of the AAA bursting is estimated from its diameter. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Sinerem administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2008to Jun 2010
- Phase
- Phase 2/3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AAA measuring >40mm in AP diameter on ultrasound scanning
- Age >40 years (patients younger than this with AAA may have a connective tissue disorder and a different aetiology to their disease)
- Considered to be suitable for standard infra-renal open surgical repair
Who cannot join
- Patients who are not deemed to be fit for open surgical repair
- Patients who are deemed to be suitable for a stent graft performed by the radiologists rather than the standard operation
- Contraindication to MRI scanning identified from MRI Safety Questionnaire (see attached)or claustrophobia
- Age <40 years
- Patients requiring emergent repair such that there is insufficient time available to complete the protocol
- Patients refusing to give consent
Show all 13Show fewer
- Patients unable to give consent
- Pregnant women (contrast is teratogenic in animals)
- Intercurrent illness (may confound the results)
- Patients with a systemic inflammatory disorder or underlying malignancy
- Patients who require an emergency operation such that there is insufficient time to complete the study protocol
- Renal dysfunction (Creat >250 or eGFR<25)
- Hepatic dysfunction (Child's grade B or C)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh/Royal Infirmary of Edinburgh
Edinburgh, Midlothian, Eh16 4SA
About this study
Abdominal aortic aneurysm (AAA) is a progressive enlargement of the aorta, the largest blood vessel in the body. It is at risk of bursting when it is usually fatal. Currently the risk of the AAA bursting is estimated from its diameter. In this study, the investigators hope to develop a new type of aneurysm scan involving Magnetic Resonance Imaging (MRI). It is hoped that this scan will be better at determining which AAAs are at risk of bursting and therefore require an operation to prevent this.
Read the detailed description
Abdominal aortic aneurysms (AAA) have a prevalence of ~5% and when ruptured carry a mortality rate of ~90%. The pathophysiology of AAA encompasses a range of poorly understood biomechanical and biological processes. Currently the diameter of the aneurysm is used as a surrogate for the risk of rupture and patients with an aneurysm diameter greater than 55 mm are considered for elective surgical repair. However, this reliance on a single surrogate measure is too simplistic and does not take into account other physical and biological aspects of the AAA. We propose to evaluate the role of inflammation, proteolysis and neovascularisation in patients with AAA disease. We will compare novel magnetic resonance imaging techniques with blood and tissue measures of inflammation (c-reactive protein, cytokines, macrophage and leucocyte density), proteolytic activity (matrix metalloproteinases, tissue inhibitors of metalloproteinases) and neovascularisation (vessel density, endothelial progenitor cells). By comparing findings between patients with symptomatic and asymptomatic disease, this study will inform our understanding of the disease process as well as potentially identify risk markers of AAA instability that could be used to follow-up patients with asymptomatic disease.
- Conditions
- Aortic Aneurysm
- Being tested
- Sinerem administration
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinerem administrationDrug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| Sinerem | Experimental | MRI scanning of patients with AAA before and 24hrs +/- 4hrs after administration of Sinerem Receives: Drug: Sinerem administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in signal intensity in a Region of Interest on MRI scanning
Measured: 24 hours after administration of Sinerem
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- David E Newby, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794092
- Sponsor's protocol ID
- 2007/R/CAR/15
- Status last verified
- Jun 2021
- First submitted
- 17 Nov 2008
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Richards JM, Semple SI, MacGillivray TJ, Gray C, Langrish JP, Williams M, Dweck M, Wallace W, McKillop G, Chalmers RT, Garden OJ, Newby DE. Abdominal aortic aneurysm growth predicted by uptake of ultrasmall superparamagnetic particles of iron oxide: a pilot study. Circ Cardiovasc Imaging. 2011 May;4(3):274-81. doi: 10.1161/CIRCIMAGING.110.959866. Epub 2011 Feb 8.
PubMed 21304070
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of Aortic Aneurysm Instability
- ClinicalTrials.gov ID
- NCT00794092
- Acronym / sponsor ID
- 2007/R/CAR/15
- Conditions
- Aortic Aneurysm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Nov 2008 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Nov 2008 (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.
Abdominal aortic aneurysm (AAA) is a progressive enlargement of the aorta, the largest blood vessel in the body. It is at risk of bursting when it is usually fatal. Currently the risk of the AAA bursting is estimated from its diameter. In this study, the investigators hope to develop a new type of aneurysm scan involving Magnetic Resonance Imaging (MRI). It is hoped that this scan will be better at determining which AAAs are at risk of bursting and therefore require an operation to prevent this.
Detailed description
Abdominal aortic aneurysms (AAA) have a prevalence of ~5% and when ruptured carry a mortality rate of ~90%. The pathophysiology of AAA encompasses a range of poorly understood biomechanical and biological processes. Currently the diameter of the aneurysm is used as a surrogate for the risk of rupture and patients with an aneurysm diameter greater than 55 mm are considered for elective surgical repair. However, this reliance on a single surrogate measure is too simplistic and does not take into account other physical and biological aspects of the AAA. We propose to evaluate the role of inflammation, proteolysis and neovascularisation in patients with AAA disease. We will compare novel magnetic resonance imaging techniques with blood and tissue measures of inflammation (c-reactive protein, cytokines, macrophage and leucocyte density), proteolytic activity (matrix metalloproteinases, tissue inhibitors of metalloproteinases) and neovascularisation (vessel density, endothelial progenitor cells). By comparing findings between patients with symptomatic and asymptomatic disease, this study will inform our understanding of the disease process as well as potentially identify risk markers of AAA instability that could be used to follow-up patients with asymptomatic disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinerem | Experimental | Drug: Sinerem administrationMRI scanning of patients with AAA before and 24hrs +/- 4hrs after administration of Sinerem |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AAA measuring >40mm in AP diameter on ultrasound scanning
- Age >40 years (patients younger than this with AAA may have a connective tissue disorder and a different aetiology to their disease)
- Considered to be suitable for standard infra-renal open surgical repair
Key exclusion criteria (13 listed)
- Patients who are not deemed to be fit for open surgical repair
- Patients who are deemed to be suitable for a stent graft performed by the radiologists rather than the standard operation
- Contraindication to MRI scanning identified from MRI Safety Questionnaire (see attached)or claustrophobia
- Age <40 years
- Patients requiring emergent repair such that there is insufficient time available to complete the protocol
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 |
|---|---|---|
| Sinerem administrationSingle dose | Drug | Sinerem |
Primary outcome
Change in signal intensity in a Region of Interest on MRI scanning
Time frame: 24 hours after administration of Sinerem
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 21 Jun 2021.
- Results publication: PubMed 21304070Richards JM, Semple SI, MacGillivray TJ, Gray C, Langrish JP, Williams M, Dweck M, Wallace W, McKillop G, Chalmers RT, Garden OJ, Newby DE. Abdominal aortic aneurysm growth predicted by uptake of ultrasmall superparamagnetic particles of iron oxide: a pilot study. Circ Cardiovasc Imaging. 2011 May;4(3):274-81. doi: 10.1161/CIRCIMAGING.110.959866. Epub 2011 Feb 8.
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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.
David E Newby principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sinerem administration in people with Aortic Aneurysm, run by University of Edinburgh at 1 site in United Kingdom.
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 3 inclusion and 13 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 21 Jun 2021. 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 United Kingdom. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in signal intensity in a Region of Interest on MRI scanning (time frame: 24 hours after administration of Sinerem). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794092, which also lists 1 linked publication.
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 21 Jun 2021.