Clinical trial NCT03362710: Simplified and Easy Detection of Arterial Disease in Nursing Homes
Official title: Evaluation du Risque Vasculaire Par Mesures Non Invasives en Soins Primaires.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Artery Disease, Peripheral
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-12-05
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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:

1. Skin temperature on the back of the foot with infra-red thermometry
2. Toe saturometry
3. ABI with an automatic sphygmomanometry
4. Skin Recoloration time at the foot

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Performance of non-invasive measurements
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: UH Angers
name: Samir HENNI, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: