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临床试验/NCT06318767
NCT06318767已完成不适用

Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2024年3月7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
134
试验地点
2
主要终点
occurrence of limb ischemia

研究概览

简要总结

Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%).

It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE).

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients at least 18 years old,
  • willing and able to provide written informed consent,
  • with documented atherosclerosis critical limb ischemia (pain rest and/or ulcer and gangrene manifestations)
  • with hemodynamic measures (ankle pressure less than 50mmHg and/or TBI less than 30mmHg and/or TcPO2 less than 30 mmHg),
  • followed or send to CHU Amiens Picardie, and eligible to chirurgical revascularization.

排除标准

  • with non atherosclerosis arteriopathy,
  • ineligible to the gold standard treatment such as the chirurgical revascularization,
  • with life expectancy less than 3 months.

结局指标

主要结局

occurrence of limb ischemia

时间窗: 6 months

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 (2)

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