TiVi Evaluation of Microcirculatory Reactivity of the Skin to Galvanic Stimulation: Effect of Aspirin (PIRAAT)

June 23, 2022 updated by: University Hospital, Angers

Performance du TiVi Pour évaluer la réactivité Microcirculatoire de la Peau à l'Application d'un Courant Galvanique, Effet de l'Aspirine

Prospective interventional study. The aim is to analyze the effect of usual ongoing treatments over microvascular cutaneous response to galvanic current applications (CIV: current induced vasodilatation) with tissue vitality (TiVi) system on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response.

This test could make it possible to detect the functional effects of low dose aspirin without using biological tests. A routine clinical application could be to use this CIV to verify adherence to aspirin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

830

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49100
        • Uh Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PAD patients

Experimental: 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 TiVi system
Device: TiVi system

Device: TiVi system 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 TiVi system 10 minutes later.

Measurement of the value of skin blood flow (by TiVi system) at the stimulated area as compare to a non stimulated adjacent skin value taken as a reference Usual treatment will be recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factor associated with CIV amplitude
Time Frame: 10 minutes after the second period of current application
Determination of the coefficient r² characterizing the quality of the univariate linear regression explaining the Delta2 (maximum differential amplitude of the response to galvanic current between stimulated and non-stimulated zone) by the quantity of aspirin administered (expressed in mg).
10 minutes after the second period of current application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of aspirin in impaired CIV
Time Frame: 10 minutes after the second period of current application
Likelihood ratio comparison of the univariate model to a multivariate model including all factors, primarily medicated, that may be associated with impaired CIV in vascular patients
10 minutes after the second period of current application
Determination of the CIV cut-off value to optimally discriminate patients on aspirin from patients not taking aspirin
Time Frame: 10 minutes after the second period of current application
Delta2 value (threshold CIV) minimizing distance to 100/100% sensitivity / specificity of receiver operating characteristics (ROC) analysis
10 minutes after the second period of current application
Survival rate without major cardiovascular event (MACE) in patients with or without aspirin
Time Frame: at 12 months and 24 months
the event-free survival rate is defined as the time between the inclusion date and the event date. If no event is observed at 24 months
at 12 months and 24 months
Survival rate without major cardiovascular event (MACE)in patients with aspirin according to the CIV response.
Time Frame: at 12 months and 24 months.
the event-free survival rate is defined as the time between the inclusion date and the event date. If no event is observed at 24 months
at 12 months and 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2018

Primary Completion (ACTUAL)

September 26, 2021

Study Completion (ACTUAL)

September 26, 2021

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (ACTUAL)

November 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A02528-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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