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

Primary Purpose

Artery Disease, Peripheral

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
simplified tools
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Artery Disease, Peripheral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Angers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PAD patients

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 29, 2017
Last Updated
March 30, 2022
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT03362710
Brief Title
Simplified and Easy Detection of Arterial Disease in Nursing Homes
Acronym
First-SEDAN
Official Title
Evaluation du Risque Vasculaire Par Mesures Non Invasives en Soins Primaires.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artery Disease, Peripheral

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAD patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
simplified tools
Intervention Description
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
Primary Outcome Measure Information:
Title
Performance of non-invasive measurements
Description
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
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir HENNI, MD,PhD
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Simplified and Easy Detection of Arterial Disease in Nursing Homes

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