Peripheral Arterial DiseasePIRAATNCT03357367
TiVi Evaluation of Microcirculatory Reactivity of the Skin to Galvanic Stimulation: Effect of Aspirin
A study testing TiVi system in people with Peripheral Arterial Disease, run by University Hospital, Angers at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- TiVi system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2018to 26 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- pregnancy
- inability to understand the study goal
- Patients protected by decision of law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance du TiVi Pour évaluer la réactivité Microcirculatoire de la Peau à l'Application d'un Courant Galvanique, Effet de l'Aspirine
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- TiVi system
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiVi systemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: TiVi system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 minutes after the second period of current application
Secondary outcomes (4)
Role of aspirin in impaired CIV
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
Measured: 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
Delta2 value (threshold CIV) minimizing distance to 100/100% sensitivity / specificity of receiver operating characteristics (ROC) analysis
Measured: 10 minutes after the second period of current application
Survival rate without major cardiovascular event (MACE) in patients with or without aspirin
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
Measured: at 12 months and 24 months
Survival rate without major cardiovascular event (MACE)in patients with aspirin according to the CIV response.
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
Measured: at 12 months and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start8 Feb 2018
- Primary completion26 Sep 2021
- Study completion26 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Samir MD HENNI, PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357367
- Sponsor's protocol ID
- 2017-A02528-45
- Acronym
- PIRAAT
- Status last verified
- Jun 2022
- First submitted
- 20 Nov 2017
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33161777
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance du TiVi Pour évaluer la réactivité Microcirculatoire de la Peau à l'Application d'un Courant Galvanique, Effet de l'Aspirine
- ClinicalTrials.gov ID
- NCT03357367
- Acronym / sponsor ID
- PIRAAT / 2017-A02528-45
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 26 Sep 2021 (actual)
- Study completion
- 26 Sep 2021 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAD patients | Experimental | Device: TiVi systemExperimental: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- pregnancy
- inability to understand the study goal
- Patients protected by decision of law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiVi systemDevice: 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 | Device | PAD patients |
Primary outcome
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).
4 secondary outcomes
Role of aspirin in impaired CIV
Time frame: 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
Time frame: 10 minutes after the second period of current application
Survival rate without major cardiovascular event (MACE) in patients with or without aspirin
Time frame: at 12 months and 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Derived from this study: PubMed 33161777Ramondou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir MD HENNI, PhD principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TiVi system in people with Peripheral Arterial Disease, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factor associated with CIV amplitude (time frame: 10 minutes after the second period of current application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03357367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.