- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00794092
Magnetic Resonance Imaging of Aortic Aneurysm Instability
June 17, 2021 updated by: University of Edinburgh
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 2
- Phase 3
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
-
-
Midlothian
-
Edinburgh, Midlothian, United Kingdom, Eh16 4SA
- University of Edinburgh/Royal Infirmary of Edinburgh
-
-
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
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
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
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sinerem
MRI scanning of patients with AAA before and 24hrs +/- 4hrs after administration of Sinerem
|
Single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in signal intensity in a Region of Interest on MRI scanning
Time Frame: 24 hours after administration of Sinerem
|
24 hours after administration of Sinerem
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (ACTUAL)
November 1, 2008
Primary Completion (ACTUAL)
June 1, 2010
Study Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
November 17, 2008
First Submitted That Met QC Criteria
November 18, 2008
First Posted (ESTIMATE)
November 19, 2008
Study Record Updates
Last Update Posted (ACTUAL)
June 21, 2021
Last Update Submitted That Met QC Criteria
June 17, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007/R/CAR/15
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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