Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms

University of Edinburgh

Status: Terminated

Conditions: Abdominal Aortic Aneurysm

Study type: Observational

Funder types: Other

Identifiers

NCT01749280

10336

2011/R1CARl05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

16 participants in 1 patient group

Abdominal Aortic Aneurysms

Description:

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.