Peripheral Arterial DiseasePRECARNCT03693053
Socioeconomic Deprivation and Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2017to 13 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were recruited from * Vascular medicine and surgery department of Grenoble university hospital * Or therapeutic education consultation. These consultations took place in Grenoble reference center of therapeutic education CREPvAL Granted as part of education program: "On the move! Better understand and better live your PAD".
Who may be able to join
- Male or female,
- Age 18 years or older,
- Symptomatic PAD (stage 2 or 3)
Who cannot join
- Pregnant woman
- Person under administrative or judicial supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Level of Precariousness in a Population of Patients With Symptomatic Peripheral Arterial Disease.
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.
Read more
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.
- Conditions
- Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (2)
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
Measured: one day
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start2 Oct 2017
- Primary completion13 Jul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693053
- Sponsor's protocol ID
- 38RC17.212
- Other IDs
- 2017-A02063-50
- Acronym
- PRECAR
- Status last verified
- Oct 2018
- First submitted
- 31 Jul 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Level of Precariousness in a Population of Patients With Symptomatic Peripheral Arterial Disease.
- ClinicalTrials.gov ID
- NCT03693053
- Acronym / sponsor ID
- PRECAR / 38RC17.212
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from * Vascular medicine and surgery department of Grenoble university hospital * Or therapeutic education consultation. These consultations took place in Grenoble reference center of therapeutic education CREPvAL Granted as part of education program: "On the move! Better understand and better live your PAD".
Key inclusion criteria (3 listed)
- Male or female,
- Age 18 years or older,
- Symptomatic PAD (stage 2 or 3)
Key exclusion criteria (2 listed)
- Pregnant woman
- Person under administrative or judicial supervision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of precariousness in patients with symptomatic PAD
Time frame: 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.
2 secondary outcomes
Level of precariousness by EPICES score between stage 2 and stage 3 of symptomatic PAD.
Time frame: one day
Links between the level of precariousness by EPICES score and cardiovascular risk factors.
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of precariousness in patients with symptomatic PAD (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.