Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms

NCT01749280 | Terminated

• 2 other identifiers: 2011/R1CARl0510336
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm; MRI; USPIO

Outcome Measures

Primary Outcomes (2)

• 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.

  The change of R2\* signal which is determined by the USPIO uptake within the issues will be used to assess the change between pre-and post contrast MRI scans. The investigators will assess if macrophage activity as determined by USPIO change predicts AAA growth and rupture

  2 yrs

• Does USPIO uptake as determined by percentage change between pre-and post contrast scan co-relates with FDG PET standardised uptake values or tissue to background ratios.

  As per ethical approval, we have recruited patients under AAA PET study to look at USPIO correlation with 18F-FDG PET. The cellular inflammation can be assessed by USPIO uptake, whilst the metabolic activity can be determined by 18F-FDG PET. In this study, the investigators will determine if there is a correlation between the these two imaging modalties by comparing the R2\* change using MRI and standardised uptake values using FDG PET.

  2 yrs

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit 237 patients with abdominal aortic aneurysms from the clinical surveillance programme at the Royal Infirmary, Edinburgh. Inclusion criteria will be patients with an abdominal aortic aneurysm \>40 mm on ultrasound scanning. Exclusion criteria will include patients with anticipated or planned abdominal aortic aneurysm repair, women of child-bearing potential without contraception, inability to undergo magnetic resonance or computed tomography scanning, life expectancy of \<2 years, and those with any form of collagen-vascular disease.

You may qualify if:

• Patients with an abdominal aortic aneurysm \>40 mm

You may not qualify if:

• Subjects with planned AAA surgery.
• Renal impairment with eGFR of \<30 mls/min at screening, history of kidney transplant or history of contrast nephropathy.
• Women of child-bearing potential without contraception,
• Collagen-vascular disease.
• Inability to undergo magnetic resonance or computed tomography scanning,
• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• University of Cambridge: collaborator

Study Sites (1)

Clinical Research Imaging Centre/ NHS LOTHIAN

Edinburgh, EH16 4SB, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• David Newby, MD PhD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 13, 2012
• Study Start: March 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

GB (1)