Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms

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 Type

Observational

Primary Outcome

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.

Condition

Abdominal Aortic Aneurysm

Study Arms / Comparison Groups

 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.

Publications

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

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 <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.
      

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

No

Contacts

David Newby, MD PhD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

NCT ID

NCT01749280

Organization ID

2011/R1CARl05

Secondary IDs

10336

Responsible Party

Sponsor

Study Sponsor

University of Edinburgh

Collaborators

 University of Cambridge

Study Sponsor

David Newby, MD PhD, Principal Investigator, University of Edinburgh

Verification Date

December 2012