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First Approach for Aspirin Misuse Objective Screening

NCT ID: NCT02997436

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-04

Study Completion Date

2017-04-10

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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Laser speckle flowmetry

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Sophie Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Pierre Abraham, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Philippe Bouye, MD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Valmont Richard, MD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Vincent Azzola, MD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Locations

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UH Angers

Angers, , France

Site Status

Countries

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France

Other Identifiers

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2016-A01157-44

Identifier Type: -

Identifier Source: org_study_id