ACTRN12622000442707招募中未知
The feasibility of 18F-FMISO imaging for atherosclerotic and non-atherosclerotic intra-arterial hypoxia in the setting of peripheral arterial disease requiring amputation.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40 Years 至 o limit(—)
- 性别
- All
入选标准
- •Male or post-menopausal female (defined as the absence of menses of >12 months in the absence of pathology) above the age 40 who have undergone a clinical decision to proceed to below knee or above knee amputation
- •-A lower limb computed-tomography angiography performed in the last 18 months and performed exclusively for clinical purposes
- •-Have some evidence of arterial disease on lower limb computed-tomography angiography
排除标准
- •-Inability to provide informed consent
- •-A diagnosis of chronic obstructive pulmonary disease or other respiratory disease that currently requires home oxygen therapy
- •-A resting oxygen saturation (measured at time of screening and in the absence of oxygen therapy) below 92%
- •-eGFR less than or equal to 30 at time of screening
- •-Symptomatic heart failure impairing an ability to lie flat on for imaging purposes or requiring supplemental oxygen therapy
- •-A prior below knee, above knee or higher, lower limb amputation of the other limb
- •-Acute lower limb ischemia requiring urgent revascularisation or emergent amputation
- •-Prior orthopaedic surgery of the lower limb with foreign material remaining in-situ
- •-In-patients requiring nurse escort for inter-hospital transport
- •-Recent or current lung cancer or cancer of the lower limb (excluding Non-melanoma skin cancer)
- •-Known cardiac arrhythmia that precludes ECG gating
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