Socioeconomic Deprivation and Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— PRECAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03693053
• Other study ID #: 38RC17.212
• Secondary ID: 2017-A02063-50
• Status: Completed
• Start date: October 2, 2017
• Est. completion date: July 13, 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 13, 2018
• Est. primary completion date: July 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female,

• Age 18 years or older,

• Symptomatic PAD (stage 2 or 3)

Exclusion Criteria:

• Pregnant woman

• Person under administrative or judicial supervision

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
France	University Hospital	Grenoble	Isere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of precariousness in patients with symptomatic PAD	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.	one day
Secondary	Level of precariousness by EPICES score between stage 2 and stage 3 of symptomatic PAD.	Stade 2 : exercise ischemia stage Stade 3 : rest ischemia stage	one day
Secondary	Links between the level of precariousness by EPICES score and cardiovascular risk factors.	Cardiovascular risk factors were: Hypertension was defined as a systolic blood pressure of 140 mm Hg or higher, or a diastolic blood pressure of 90 mm Hg or higher, or current use of antihypertensive drugs.; Hypercholesterolemia was defined as LDL cholesterol levels of 0,7 g/l or higher or current use statin.; Subjects were considered to have diabetes mellitus if they reported a physician diagnosis of diabetes mellitus, were taking prescription medications for diabetes mellitus (either insulin or oral agents).; Subjects were classified into groups of current smokers, former smokers (smoking cessation for more than 9 months) and non-smokers.	one day