TiVi Evaluation of Microcirculatory Reactivity of the Skin to Galvanic Stimulation: Effect of Aspirin (PIRAAT)
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| ClinicalTrials.gov Identifier: NCT03357367 |
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Recruitment Status :
Recruiting
First Posted : November 29, 2017
Last Update Posted : June 3, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Peripheral Arterial Disease | Device: TiVi system | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 830 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Performance du TiVi Pour évaluer la réactivité Microcirculatoire de la Peau à l'Application d'un Courant Galvanique, Effet de l'Aspirine |
| Actual Study Start Date : | February 8, 2018 |
| Estimated Primary Completion Date : | September 26, 2021 |
| Estimated Study Completion Date : | September 26, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: PAD patients
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
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 |
- Factor associated with CIV amplitude [ Time Frame: 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).
- Role of aspirin in impaired CIV [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357367
| Contact: Samir MD HENNI, PhD | 33(0)241354617 | samir.henni@chu-angers.fr | |
| Contact: Pierre MD ABRAHAM, PhD | 33(0)241354617 | paabraham@chu-angers.fr |
| France | |
| UH Angers | Recruiting |
| Angers, France, 49100 | |
| Contact: Samir MD HENNI, PhD 33(0)241354617 samir.henni@chu-angers.fr | |
| Contact: Pierre MD ABRAHAM, PhD 33(0)241354617 piabraham@chu-angers.fr | |
| Principal Investigator: Samir MD HENNI, PhD | |
| Sub-Investigator: Pierre MD ABRAHAM, PhD | |
| Sub-Investigator: Philippe MD BOUYE | |
| Sub-Investigator: Marie-Sophie MD FERNANDEZ-LEGRAND | |
| Sub-Investigator: Valmont MD RICHARD | |
| Sub-Investigator: Tanguy MD LE MELINIER | |
| Sub-Investigator: Anne-Sophie MD GOURDIER | |
| Sub-Investigator: Vincent MD AZZOLA | |
| Sub-Investigator: Jean MD PICQUET, PhD | |
| Principal Investigator: Wassim MD MOKADDEM | |
| Principal Investigator: | Samir MD HENNI, PhD | UH Angers |
| Responsible Party: | University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT03357367 |
| Other Study ID Numbers: |
2017-A02528-45 |
| First Posted: | November 29, 2017 Key Record Dates |
| Last Update Posted: | June 3, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |