Performance du TiVi Pour évaluer la réactivité Microcirculatoire de la Peau à l'Application d'un Courant Galvanique, Effet de l'Aspirine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 830
- 试验地点
- 2
- 主要终点
- Factor associated with CIV amplitude
研究概览
简要总结
Prospective interventional study. The aim is to analyze the effect of usual ongoing treatments over microvascular cutaneous response to galvanic current applications (CIV: current induced vasodilatation) with tissue vitality (TiVi) system on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response.
This test could make it possible to detect the functional effects of low dose aspirin without using biological tests. A routine clinical application could be to use this CIV to verify adherence to aspirin.
详细描述
At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed.
No register of non-included patients will be kept. In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, microvascular investigation will be performed as explained later in arm description.
Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •subjects referred for investigation of peripheral arterial disease.
- •Affiliation to the French National healthcare system
- •French speaking patients
- •Ability to stand still for half a minute.
排除标准
- •pregnancy
- •inability to understand the study goal
- •Patients protected by decision of law
结局指标
主要结局
Factor associated with CIV amplitude
时间窗: 10 minutes after the second period of current application
Determination of the coefficient r² characterizing the quality of the univariate linear regression explaining the Delta2 (maximum differential amplitude of the response to galvanic current between stimulated and non-stimulated zone) by the quantity of aspirin administered (expressed in mg).
次要结局
- Role of aspirin in impaired CIV(10 minutes after the second period of current application)
- Determination of the CIV cut-off value to optimally discriminate patients on aspirin from patients not taking aspirin(10 minutes after the second period of current application)
- Survival rate without major cardiovascular event (MACE) in patients with or without aspirin(at 12 months and 24 months)
- Survival rate without major cardiovascular event (MACE)in patients with aspirin according to the CIV response.(at 12 months and 24 months.)