Simplified and Easy Detection of Arterial Disease in Nursing Homes (First-SEDAN)

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

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.

Study Overview

• Status: Completed
• Conditions: Artery Disease, Peripheral
• Intervention / Treatment: Diagnostic test: simplified tools

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

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: PAD patients; Patients referred for an arterial doppler assessment of lower limbs will be included. Intervention is a series of examination, followed by the measurement of the ABI and an arterial echo-doppler of the lower limbs +/- transcutaneous oxygen pressure measurements in case of suspected critical limb ischemia. A technician will perform the evaluation with simplified tools blinded to the results of vascular specialised investigations

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Samir HENNI, MD,PhD, UH Angers

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 9, 2018
• Primary Completion (ACTUAL): March 30, 2022
• Study Completion (ACTUAL): March 30, 2022

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (ACTUAL): December 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 2017-A02635-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No