A Phase 2/3 interventional study of Sinerem administration in Aortic Aneurysm, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by University of Edinburgh · Phase 2/3, Interventional, and Diagnostic
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.
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.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's enrollment of 29 is below the median of 72 across 462 interventional studies indexed under Aneurysm.
Browse Aneurysm studies →University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MRI scanning of patients with AAA before and 24hrs +/- 4hrs after administration of Sinerem
Drug: Sinerem administration
Single dose
Change in signal intensity in a Region of Interest on MRI scanning
Time frame: 24 hours after administration of Sinerem
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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University of Edinburgh