First Approach for Aspirin Misuse Objective Screening

NCT02997436 | Completed DMC

• 1 other identifier: 2016-A01157-44
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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 .

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PAD patients

EXPERIMENTAL

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

Interventions

Laser speckle flowmetry 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

PAD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnancy
• inability to understand the study goal
• Patients protected by decision of law

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

UH Angers

Angers, 49100, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 20, 2016
• Study Start: January 4, 2017
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2017
• Last Updated: November 1, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)