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临床试验/NCT00794092
NCT00794092已完成2 期

Magnetic Resonance Imaging of Aortic Aneurysm Instability

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
29
试验地点
1
主要终点
Change in signal intensity in a Region of Interest on MRI scanning

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Sinerem

Experimental

MRI scanning of patients with AAA before and 24hrs +/- 4hrs after administration of Sinerem

干预措施: Sinerem administration (Drug)

结局指标

主要结局

Change in signal intensity in a Region of Interest on MRI scanning

时间窗: 24 hours after administration of Sinerem

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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