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临床试验/NCT03693053
NCT03693053已完成不适用

Assessment of the Level of Precariousness in a Population of Patients With Symptomatic Peripheral Arterial Disease.

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Level of precariousness in patients with symptomatic PAD

研究概览

简要总结

Atherosclerosis is a systemic disease that affects coronary, cerebral, and lower-extremity arteries. Peripheral artery disease (PAD) is the manifestation of atherosclerosis in the legs. Three different stages can be found: asymptomatic stage (stage 1), exercise ischemia stage (stage 2) and rest ischemia stage (stage 3). The risk factors for PAD are similar to those for coronary artery disease (CAD) and cerebrovascular disease (CBVD), like high blood pressure, diabetes, smoking, dyslipidemia and obesity. But cigarette smoking is the single most important risk factor for the development and progression of PAD.

PAD is a serious illness and an important predictor of cardiovascular disease with major medico-economic consequences.

A low socioeconomic status (SES) is associated with higher cardiovascular mortality and morbidity. In these vulnerable populations, there is an increase in the prevalence of cardiovascular risk factors, particularly for smoking.

The main objective of this study was to assess the level of precariousness in patients with symptomatic PAD and compare it to the level of precariousness in the general population.

Patients were recruited from vascular medicine and surgery department of Grenoble university hospital or therapeutic education outpatient consultation.

The analysis of socio-economic and environmental data resulted in:

  • EPICES score: (Evaluation of the Deprivation and Inequalities of Health in Healthcare Centers score). The EPICES score is a quick and validated questionnaire to assess precariousness at the individual level, developed by considering all the material and psychosocial dimensions of precariousness.

Precariousness, according to the EPICES score, in the general population is estimated at 40%.

  • INSEE parameters. The investigators completed the EPICES score with more traditional indicators derived from The National Institute of Statistics and Economic Studies (INSEE) collects, analyses and disseminates information on the French economy and society. The investigators collected the level of education and professional practice based on the nomenclature of socio-professional categories defined by INSEE.

Cardiovascular risk factors were also collected to measure the links between the level of precariousness and cardiovascular risk factors.

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

入选标准

  • Male or female,
  • Age 18 years or older,
  • Symptomatic PAD (stage 2 or 3)

排除标准

  • Pregnant woman
  • Person under administrative or judicial supervision

结局指标

主要结局

Level of precariousness in patients with symptomatic PAD

时间窗: one day

The level of precariousness is measured by EPICES score : It consists of 11 items related to isolation, health insurance status, economic status, social support and leisure activity. For each item, a binary response Yes/No is expected from the patient. The total score ranges from 0 to 100, from lack to the highest social deprivation. Patients were considered precarious if their score is superior to threshold of 30.

次要结局

  • Level of precariousness by EPICES score between stage 2 and stage 3 of symptomatic PAD.(one day)
  • Links between the level of precariousness by EPICES score and cardiovascular risk factors.(one day)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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