Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Abdominal Aortic Aneurysm

Keywords

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Abdominal Aortic Aneurysm MRI USPIO

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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 \<30 mls/min at screening, history of kidney transplant or history of contrast nephropathy.
4. Women of child-bearing potential without contraception,
5. Collagen-vascular disease.
6. Inability to undergo magnetic resonance or computed tomography scanning,
7. Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but not limited to:

* Intracranial aneurysm clips (except Sugita) or other metallic objects,
* History of intra- orbital metal fragments that have not been removed,
* Pacemakers, implantable cardiac defibrillators and non-MR compatible heart valves,
* Inner ear implants,
* History of claustrophobia in MR.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Newby, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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Clinical Research Imaging Centre/ NHS LOTHIAN

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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10336

Identifier Type: REGISTRY

Identifier Source: secondary_id

2011/R1CARl05

Identifier Type: -

Identifier Source: org_study_id