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

Peripheral Arterial Disease Clinical Trial

— PIRAAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357367
• Other study ID #: 2017-A02528-45
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: September 26, 2021

Study information

• Verified date: June 2022
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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: 830
• Est. completion date: September 26, 2021
• Est. primary completion date: September 26, 2021
• 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:
• 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

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	Factor associated with CIV amplitude	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	Role of aspirin in impaired CIV	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
Secondary	Determination of the CIV cut-off value to optimally discriminate patients on aspirin from patients not taking aspirin	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
Secondary	Survival rate without major cardiovascular event (MACE) in patients with or without aspirin	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
Secondary	Survival rate without major cardiovascular event (MACE)in patients with aspirin according to the CIV response.	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.