First Approach for Aspirin Misuse Objective Screening (FirstAMOS)

University Hospital, Angers

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Laser speckle flowmetry

Study type: Interventional

Funder types: Other

Identifiers

NCT02997436

2016-A01157-44

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

PAD patients

Experimental group

Description:

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

Treatment:

Device: Laser speckle flowmetry