Skip to main content
OpenTrials
Completed

NCT Number: NCT03357367

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Angers

Angers, 49100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TiVi system

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: PIRAAT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2017
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.