First Approach for Aspirin Misuse Objective Screening (FirstAMOS)

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")

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 .

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Laser speckle flowmetry

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • UH 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PAD patients; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Marie-Sophie Fernandez, MD, UH Angers; Principal Investigator: Pierre Abraham, MD, PhD, UH Angers; Principal Investigator: Philippe Bouye, MD, UH Angers; Principal Investigator: Valmont Richard, MD, UH Angers; Principal Investigator: Vincent Azzola, MD, UH Angers

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2017
• Primary Completion (Actual): April 10, 2017
• Study Completion (Actual): April 10, 2017

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2016-A01157-44

Plan for Individual participant data (IPD)

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