TiVi Evaluation of Microcirculatory Reactivity of the Skin to Galvanic Stimulation: Effect of Aspirin
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: TiVi system
- Registration Number
- NCT03357367
- Lead Sponsor
- University Hospital, Angers
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 830
- 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.
- pregnancy
- inability to understand the study goal
- Patients protected by decision of law
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PAD patients TiVi system 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
UH Angers
🇫🇷Angers, France