Magnetic Resonance Imaging of Aortic Aneurysm Instability
Primary Purpose
Aortic Aneurysm
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Sinerem administration
Sponsored by
About this trial
This is an interventional diagnostic trial for Aortic Aneurysm
Eligibility Criteria
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)
Sites / Locations
- University of Edinburgh/Royal Infirmary of Edinburgh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sinerem
Arm Description
MRI scanning of patients with AAA before and 24hrs +/- 4hrs after administration of Sinerem
Outcomes
Primary Outcome Measures
Change in signal intensity in a Region of Interest on MRI scanning
Secondary Outcome Measures
Full Information
NCT ID
NCT00794092
First Posted
November 17, 2008
Last Updated
June 17, 2021
Sponsor
University of Edinburgh
Collaborators
British Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00794092
Brief Title
Magnetic Resonance Imaging of Aortic Aneurysm Instability
Official Title
Magnetic Resonance Imaging of Aortic Aneurysm Instability
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2008 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
British Heart Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sinerem
Arm Type
Experimental
Arm Description
MRI scanning of patients with AAA before and 24hrs +/- 4hrs after administration of Sinerem
Intervention Type
Drug
Intervention Name(s)
Sinerem administration
Intervention Description
Single dose
Primary Outcome Measure Information:
Title
Change in signal intensity in a Region of Interest on MRI scanning
Time Frame
24 hours after administration of Sinerem
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Newby
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Edinburgh/Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
Eh16 4SA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21304070
Citation
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.
Results Reference
result
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Magnetic Resonance Imaging of Aortic Aneurysm Instability
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