Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms

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Disease Information

Descriptive Information
Brief Title † Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms
Official Title † Efficacy of Magnetic Resonance Imaging Using Ultrasmall Superparamagnetic Particles of Iron Oxide to Predict Clinical Outcome in Patients Under Surveillance for Abdominal Aortic Aneurysms
Brief Summary The aorta is the main blood vessel that comes out of the heart and distributes blood to the whole body. In some people, the aorta becomes swollen (aneurysm) and bursts, especially as it passes through the abdomen. These 'abdominal aortic aneurysms' often occur without symptoms and can burst or rupture without warning. This usually leads to death and represents the thirteenth commonest cause of death in the United Kingdom. In this study, we are looking at a new technique that can look at the aortic aneurysm using magnetic resonance imaging; a technique that does not require x-rays or radiation. We have recently shown that, using magnetic resonance combined with a new imaging agent USPIO, we can detect 'hotspots' of activity in these aneurysms that seem to predict which aneurysms grow rapidly, and are therefore potentially at risk of rupture. We here propose to conduct a study in Edinburgh that will invite all patients who are under surveillance because of an aneurysm. We will image these patients using this novel technique and see if we can identify which patients burst their aneurysm, have an aneurysm that grows so large it needs to have surgery, or die. This will be important to establish as it will potentially lead to a new way of managing people that could ultimately save lives. This is particularly timely as national screening and surveillance programmes are currently being launched.
Detailed Description HYPOTHESIS We hypothesise that uptake of ultrasmall supraparamagnetic particles of iron oxide into the aortic wall will predict abdominal aortic aneurysm growth and clinical outcomes.
Study Phase N/A
Study Type † Observational
Study Design † Time Perspective: Prospective
Primary Outcome Measure † To determine if uptake ultrasmall superparamagnetic particles of iron oxide as determined by percentage R2* change between pre-and post-constant scan will predict abdominal aortic aneurysm growth and rupture in patients with abdominal aortic aneurysms.
Secondary Outcome Measure †
Condition † Abdominal Aortic Aneurysm
Intervention †
Study Arms / Comparison Groups Abdominal Aortic Aneurysms Patients will be recruited from the outpatient AAA surveillance population at the vascular unit in the Royal Infirmary of Edinburgh.Potential participation in the study will be completely asymptomatic from their AAA.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 16
Start Date † March 2011
Completion Date August 2012
Primary Completion Date August 2012
Eligibility Criteria † Inclusion Criteria: Patients with an abdominal aortic aneurysm >40 mm Exclusion Criteria: 1. Any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, or clinical laboratory examination that is deemed by the principal investigator and/or designee to make the subject ineligible for inclusion. 2. Subjects with planned AAA surgery. 3. Renal impairment with eGFR of
Gender Both
Ages 40 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United Kingdom
Administrative Information
NCT ID † NCT01749280
Organization ID 2011/R1CARl05
Secondary IDs †† 10336
Responsible Party Sponsor
Study Sponsor † University of Edinburgh
Collaborators †† University of Cambridge
Investigators † Principal Investigator: David Newby, MD PhD, University of Edinburgh
Information Provided By
Verification Date December 2012
First Received Date † November 30, 2012
Last Updated Date December 11, 2012
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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