Clinical trial NCT03357367: TiVi Evaluation of Microcirculatory Reactivity of the Skin to Galvanic Stimulation: Effect of Aspirin
Official title: Performance du TiVi Pour évaluer la réactivité Microcirculatoire de la Peau à l'Application d'un Courant Galvanique, Effet de l'Aspirine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-11-29
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Factor associated with CIV amplitude
timeFrame: 10 minutes after the second period of current application
Secondary outcomes:
measure: Role of aspirin in impaired CIV
timeFrame: 10 minutes after the second period of current application
measure: Determination of the CIV cut-off value to optimally discriminate patients on aspirin from patients not taking aspirin
timeFrame: 10 minutes after the second period of current application
measure: Survival rate without major cardiovascular event (MACE) in patients with or without aspirin
timeFrame: at 12 months and 24 months
measure: Survival rate without major cardiovascular event (MACE)in patients with aspirin according to the CIV response.
timeFrame: at 12 months and 24 months.
Other outcomes:
Locations:
city: Angers
country: France
facility: UH Angers
Study officials:
affiliation: UH Angers
name: Samir MD HENNI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramondou P, Hersant J, Fouquet O, Sempore WY, Abraham P, Henni S. Current-Induced Vasodilation Specifically Detects, and Correlates With the Time Since, Last Aspirin Intake: An Interventional Study of 830 Patients. J Cardiovasc Pharmacol Ther. 2021 May;26(3):269-278. doi: 10.1177/1074248420971165. Epub 2020 Nov 7.