First Approach for Aspirin Misuse Objective Screening

Peripheral Arterial Disease Clinical Trial

— FirstAMOS  

Official title:

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")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997436
• Other study ID #: 2016-A01157-44
• Status: Completed
• Phase: N/A
• First received: December 6, 2016
• Last updated: October 30, 2017
• Start date: January 4, 2017
• Est. completion date: April 10, 2017

Study information

• Verified date: December 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 10, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
France	UH Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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