Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms

This study has been terminated.
(Study being continued as a multi centre MA3RS study.The patients will be followed up under MA3RS and AAA PET.)
Sponsor:
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01749280
First received: November 30, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition
Abdominal Aortic Aneurysm

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
    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

  • 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. [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749280

Locations
United Kingdom
Clinical Research Imaging Centre/ NHS LOTHIAN
Edinburgh, United Kingdom, EH16 4SB
Sponsors and Collaborators
University of Edinburgh
University of Cambridge
Investigators
Principal Investigator: David Newby, MD PhD University of Edinburgh
  More Information

Additional Information:
No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01749280     History of Changes
Other Study ID Numbers: 2011/R1CARl05, 10336
Study First Received: November 30, 2012
Last Updated: December 11, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Edinburgh:
Abdominal Aortic Aneurysm
MRI
USPIO

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014