Evaluation du Risque Vasculaire Par Mesures Non Invasives en Soins Primaires.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Performance of non-invasive measurements
研究概览
简要总结
Peripheral artery disease (PAD) affects mainly elderly patients. The ankle brachial index (ABI) and ultrasound imaging are the standard diagnostic tools in PAD diagnostic and severity estimation. Measurements are generally performed by a vascular physician. However, access to medical specialist is becoming increasingly difficult with long waiting times while the aging of the population increases, while most of these patients are seen by the general practitioner.
To date, there is a lot of data in the literature on the value of using various ambulatory devices in the diagnosis and severity estimation of PAD but studied one by one.
The investigators propose to compare the measurements made by a series of simple non-invasive ambulatory tools with the measurements performed by the vascular specialist. The investigators wish to demonstrate that a series of simple and economical tools, available to paramedical health professionals can diagnose PAD and evaluate ts severity the reducing the direct and indirect associated costs.
详细描述
Patients referred for an arterial vascular investigations of the lower limbs will be included.
After signing the consent, all included patients will be assessed by the examination series, among which ABI measurement and an arterial Doppler ultrasound of the lower limbs +/- transcutaneous oxygen pressure recording in case of suspected critical limb ischemia. Following the visit patients will be classified as have or not PAD and in case of PAD classified for the severity of PAD on the basis of the investigation results.
Blinded to the results of the vascular laboratory test, a technician will:
Measure ABI with an automatic sphygmomanometer.
Examination series:
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
- 否
入选标准
- •Patients referred for arterial assessment of the lower limbs as part of a screening or follow-up of PAD
- •Patients without contraindications for all non-invasive measures
- •Age superior to 18 years
- •Affiliated patients of a social security scheme
- •Patients who have signed informed consent.
排除标准
- •Patients protected by law
- •Patients unable to understand the objectives or instructions of the study
- •Patients in an exclusion period relative to another biomedical study.
结局指标
主要结局
Performance of non-invasive measurements
时间窗: 1 hour
Performance of the score will be studied with the receiver operating characteristic (ROC) approach and multivariate analysis using echo-doppler and transcutaneous oxymetry results as references for PAD severity classification standard
次要结局
未报告次要终点