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

NCT03357367 | Completed DMC

• 1 other identifier: 2017-A02528-45
• Study Type: interventional
• Target: 830
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Role of aspirin in impaired CIV

  10 minutes after the second period of current application

• 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

• Survival rate without major cardiovascular event (MACE) in patients with or without aspirin

  at 12 months and 24 months

• Survival rate without major cardiovascular event (MACE)in patients with aspirin according to the CIV response.

  at 12 months and 24 months.

Study Arms (1)

PAD patients

EXPERIMENTAL

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

Device: TiVi system

Interventions

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

PAD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnancy
• inability to understand the study goal
• Patients protected by decision of law

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

UH Angers

Angers, 49100, France

Location

Related Publications (1)

• 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.

  PMID: 33161777 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Samir MD HENNI, PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 29, 2017
• Study Start: February 8, 2018
• Primary Completion: September 26, 2021
• Study Completion: September 26, 2021
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)