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临床试验/NCT03647566
NCT03647566已完成不适用

18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Aortic diameter

研究概览

简要总结

The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to predict disease progression in acute aortic syndrome.

详细描述

Acute Aortic Syndrome encompasses multiple aortopathies, including aortic dissection, intramural haematoma and penetrating aortic ulcers. Acute aortic syndrome has a three year mortality approaching 25%. To date, other than the initial aortic diameter, there are no accurate methods of establishing the risk of disease progression in patients with acute aortic syndrome.

In vascular disease, microcalcification occurs in response to necrotic inflammation. Using computed tomography and positron emission tomography (PET-CT), early microcalcification can be identified using uptake of the radiotracer 18F-sodium fluoride. This can identify high risk-lesions in the aorta, coronary and carotid arteries, and appears to be indicative of necrotic and heavily inflamed tissue. In abdominal aortic aneurysms, 18F-sodium fluoride binding predicts aortic expansion and the risk of aneurysm rupture or requirement for surgical repair.

The study investigators, therefore, propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic inflammation in acute aortic syndrome to predict aortic expansion and disease progression.

Control patients with a normal calibre aorta will be recruited from the National Abdominal Aortic Aneurysm Screening Programme and Vascular Out-Patient Clinics. Patients with acute aortic syndrome and chronic aortic disease will undergo clinical assessments and 18F Sodium Fluoride PET/CT scans at baseline and 12-months. Clinical follow-up will continue for up to 3 years from recruitment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Aortic diameter

时间窗: 12 months

Maximum cross-sectional aortic diameter

次要结局

  • Disease related survival(24 months)
  • Short Form-12 (SF12) questionnaire score(24 months)
  • Hospital admissions(24 months)
  • Change in renal function(24 months)
  • Surgical Intervention(24 months)
  • 18F Sodium Fluoride uptake in the aorta(12 months)
  • All-cause mortality(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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