Working… Menu

Magnetic Resonance Imaging of Aortic Aneurysm Instability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00794092
Recruitment Status : Unknown
Verified April 2010 by University of Edinburgh.
Recruitment status was:  Recruiting
First Posted : November 19, 2008
Last Update Posted : April 8, 2010
British Heart Foundation
Information provided by:
University of Edinburgh

Brief Summary:
Abdominal aortic aneurysm (AAA) is a progressive enlargement of the aorta, the largest blood vessel in the body. It is at risk of bursting when it is usually fatal. Currently the risk of the AAA bursting is estimated from its diameter. In this study, the investigators hope to develop a new type of aneurysm scan involving Magnetic Resonance Imaging (MRI). It is hoped that this scan will be better at determining which AAAs are at risk of bursting and therefore require an operation to prevent this.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Drug: Sinerem administration Phase 2 Phase 3

Detailed Description:
Abdominal aortic aneurysms (AAA) have a prevalence of ~5% and when ruptured carry a mortality rate of ~90%. The pathophysiology of AAA encompasses a range of poorly understood biomechanical and biological processes. Currently the diameter of the aneurysm is used as a surrogate for the risk of rupture and patients with an aneurysm diameter greater than 55 mm are considered for elective surgical repair. However, this reliance on a single surrogate measure is too simplistic and does not take into account other physical and biological aspects of the AAA. We propose to evaluate the role of inflammation, proteolysis and neovascularisation in patients with AAA disease. We will compare novel magnetic resonance imaging techniques with blood and tissue measures of inflammation (c-reactive protein, cytokines, macrophage and leucocyte density), proteolytic activity (matrix metalloproteinases, tissue inhibitors of metalloproteinases) and neovascularisation (vessel density, endothelial progenitor cells). By comparing findings between patients with symptomatic and asymptomatic disease, this study will inform our understanding of the disease process as well as potentially identify risk markers of AAA instability that could be used to follow-up patients with asymptomatic disease.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging of Aortic Aneurysm Instability
Study Start Date : November 2008
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sinerem
MRI scanning of patients with AAA before and 24hrs +/- 4hrs after administration of Sinerem
Drug: Sinerem administration
Single dose

Primary Outcome Measures :
  1. Change in signal intensity in a Region of Interest on MRI scanning [ Time Frame: 24 hours after administration of Sinerem ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • AAA measuring >40mm in AP diameter on ultrasound scanning
  • Age >40 years (patients younger than this with AAA may have a connective tissue disorder and a different aetiology to their disease)
  • Considered to be suitable for standard infra−renal open surgical repair

Exclusion Criteria:

  • Patients who are not deemed to be fit for open surgical repair
  • Patients who are deemed to be suitable for a stent graft performed by the radiologists rather than the standard operation
  • Contraindication to MRI scanning identified from MRI Safety Questionnaire (see attached)or claustrophobia
  • Age <40 years
  • Patients requiring emergent repair such that there is insufficient time available to complete the protocol
  • Patients refusing to give consent
  • Patients unable to give consent
  • Pregnant women (contrast is teratogenic in animals)
  • Intercurrent illness (may confound the results)
  • Patients with a systemic inflammatory disorder or underlying malignancy
  • Patients who require an emergency operation such that there is insufficient time to complete the study protocol
  • Renal dysfunction (Creat >250 or eGFR<25)
  • Hepatic dysfunction (Child's grade B or C)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00794092

Layout table for location contacts
Contact: Jennifer MJ Richards 01312423621
Contact: David E Newby 01312426515

Layout table for location information
United Kingdom
University of Edinburgh/Royal Infirmary of Edinburgh Recruiting
Edinburgh, Midlothian, United Kingdom, Eh16 4SA
Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
Layout table for investigator information
Principal Investigator: David E Newby University of Edinburgh

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Elspeth Currie, University of Edinburgh Identifier: NCT00794092     History of Changes
Other Study ID Numbers: 2007/R/CAR/15
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: April 8, 2010
Last Verified: April 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases