Peripheral Arterial Disease
Conditions
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.
Interventions
DEVICETiVi 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
Sponsors
University Hospital, Angers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Factor associated with CIV amplitude | 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
| Measure | Time frame | Description |
|---|---|---|
| Role of aspirin in impaired CIV | 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 |
| Determination of the CIV cut-off value to optimally discriminate patients on aspirin from patients not taking aspirin | 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 |
| Survival rate without major cardiovascular event (MACE) in patients with or without aspirin | 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 |
| Survival rate without major cardiovascular event (MACE)in patients with aspirin according to the CIV response. | 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 |
Countries
France
Outcome results
None listed