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Magnetic Resonance Imaging of Aortic Aneurysm Instability

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Edinburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00794092
First received: November 17, 2008
Last updated: April 7, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Aortic Aneurysm
Drug: Sinerem administration
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging of Aortic Aneurysm Instability

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Change in signal intensity in a Region of Interest on MRI scanning [ Time Frame: 24 hours after administration of Sinerem ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sinerem
MRI scanning of patients with AAA before and 24hrs +/- 4hrs after administration of Sinerem
Drug: Sinerem administration
Single dose

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.

  Eligibility

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

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)
  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: NCT00794092

Contacts
Contact: Jennifer MJ Richards 01312423621 jenny.richards@ed.ac.uk
Contact: David E Newby 01312426515 d.e.newby@ed.ac.uk

Locations
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
Investigators
Principal Investigator: David E Newby University of Edinburgh
  More Information

No publications provided by University of Edinburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elspeth Currie, University of Edinburgh
ClinicalTrials.gov Identifier: NCT00794092     History of Changes
Other Study ID Numbers: 2007/R/CAR/15
Study First Received: November 17, 2008
Last Updated: April 7, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on November 20, 2014