First Approach for Aspirin Misuse Objective Screening

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Laser speckle flowmetry

• Registration Number: NCT02997436
• Lead Sponsor: University Hospital, Angers

Brief Summary

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

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 Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-20
• Study Start: 2017-01-04
• Primary Completion: 2017-04-10
• Study Completion: 2017-04-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAD patients	Laser speckle flowmetry	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

Primary Outcome Measures

Name	Time	Method
correlation of treatments to CIV response.	10 minutes after the second period of current application	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.

Trial Locations

Locations (1)

UH Angers; 🇫🇷 Angers, France