First Approach for Aspirin Misuse Objective Screening

Study Overview
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Brief Summary
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prospective interventional study. The aim is to analyse the effect of usual ongoing treatments over the microvascular cutaneous response to galvanic current application (Current induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral artery disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response .

Detailed Description
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At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. No register of non-included patients will be kept. In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, microvascular investigation will be performed as explained later in arm description. Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

Official Title
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Asa Test ; un Nouvel Outil Dans le dépistage du Traitement Par Aspirine ? (This Official Titre is in French and Contains no Spelling Error. English Translation for it Would be : ASA-test. A New Tool for the Screening of Aspirin Treatment)

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Laser speckle flowmetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects referred for investigation of peripheral arterial disease. Affiliation to the French National healthcare system French speaking patients Ability to stand still for half a minute. Exclusion Criteria: pregnancy inability to understand the study goal Patients protected by decision of law

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAD patients<br>Patients referred for vascular ultrasound investigation for suspicion of peripheral artery disease (PAD). Intervention is measurement of microvascular response to current application on the skin by Laser speckle flowmetry | Device: Laser speckle flowmetry<br>* A galvanic current (0.1 mA) will be applied between 2 patches on the forearm of patient and protocol was repeated at 4 minutes. Microvascular response to current application (CIV) will be recorded by laser speckle flowmetry 10 minutes later. Measurement of the value of skin blood flow (by laser speckle) at the stimulated area as compare to a non stimulated adjacent skin value taken as a reference Usual treatment will be recorded<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of treatments to CIV response. | Classification of drugs in drug type categories. encoding in 1 (presence) or 0 ug (absence) of the drug category in the usual treatment of the patient. Multiple regression analysis of the different drug categories as factors influencing the increase in skin blood flow after CIV. | 10 minutes after the second period of current application |