Simplified and Easy Detection of Arterial Disease in Nursing Homes

Artery Disease, Peripheral Clinical Trial

— First-SEDAN  

Official title:

Evaluation du Risque Vasculaire Par Mesures Non Invasives en Soins Primaires.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362710
• Other study ID #: 2017-A02635-48
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: March 30, 2022

Study information

• Verified date: August 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Artery Disease, Peripheral
• Peripheral Arterial Disease

Intervention

Diagnostic Test:
• simplified tools
Skin temperature on the back of the foot with infra-red thermometry Toe saturometry ABI with an automatic sphygmomanometry Skin Recoloration time at the foot

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of non-invasive measurements	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	1 hour