Vascular DiseasesLAVNCT02861924
Locally Applied Pressure-induced Vasodilatation
A study testing microcirculatory responses in people with Vascular Diseases, run by University Hospital, Angers at 1 site in France.
Trial summary
Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- microcirculatory responses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2016to 31 Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects without vascular pathology
Who cannot join
- pregnancy
- allergy tape
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Réponse à l'Application d'Une Pression Locale en Laser Speckle Imaging Locally Applied Pressure-induced Vasodilatation
Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle).
Read the detailed description
Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle). The purpose of this study is to perform measurements of the methodological points made.
The study will investigate :
- The effect of the duration and intensity of the pressure
- The reproducibility of measurements
- The correlation with ischemic hyperemia post
- Conditions
- Vascular Diseases
- Being tested
- microcirculatory responses
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microcirculatory responsesOther
The effect of the duration and intensity of the pressure; reproducibility and correlation with ischemic hyperemia post.
measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP).
| Study group | Role | What they receive |
|---|---|---|
| microcirculatory responses | Experimental | Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle).
A pressure is applied to the subject's arm. this causes a localized ischemia. the measures responses to this ischemia will be made by the imager speckle (LSCI) give the microvascular perfusion data. Receives: Other: microcirculatory responses |
What is being measured
The primary outcome is the main question the study is designed to answer.
microcirculatory response to local pressure. Measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP).
Measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start11 Oct 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2019
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 Vascular DiseasesStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ABRAHAM, professor, Principal investigator, UH ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861924
- Sponsor's protocol ID
- 2016-A00609-42
- Acronym
- LAV
- Status last verified
- Nov 2019
- First submitted
- 19 Jul 2016
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Henni S, Hersant J, Loufrani L, Duval G, Humeau-Heurtier A; SIMS Group; Riou J, Abraham P; SOCOS Group. Painless local pressure application to test microvascular reactivity to ischemia. Microvasc Res. 2019 Mar;122:13-21. doi: 10.1016/j.mvr.2018.10.013. Epub 2018 Nov 3.
PubMed 30399363
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Réponse à l'Application d'Une Pression Locale en Laser Speckle Imaging Locally Applied Pressure-induced Vasodilatation
- ClinicalTrials.gov ID
- NCT02861924
- Acronym / sponsor ID
- LAV / 2016-A00609-42
- Conditions
- Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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.
Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle).
Detailed description
Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle). The purpose of this study is to perform measurements of the methodological points made.
The study will investigate :
- The effect of the duration and intensity of the pressure
- The reproducibility of measurements
- The correlation with ischemic hyperemia post
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microcirculatory responses | Experimental | Other: microcirculatory responsesMeasure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle). A pressure is applied to the subject's arm. this causes a localized ischemia. the measures responses to this ischemia will be made by the imager speckle (LSCI) give the microvascular perfusion data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects without vascular pathology
Key exclusion criteria (2 listed)
- pregnancy
- allergy tape
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 |
|---|---|---|
| microcirculatory responsesThe effect of the duration and intensity of the pressure; reproducibility and correlation with ischemic hyperemia post. measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP). | Other | microcirculatory responses |
Primary outcome
microcirculatory response to local pressure. Measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP).
Time frame: 2 hours
Measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP).
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 7 Nov 2019.
- Derived from this study: PubMed 30399363Henni S, Hersant J, Loufrani L, Duval G, Humeau-Heurtier A; SIMS Group; Riou J, Abraham P; SOCOS Group. Painless local pressure application to test microvascular reactivity to ischemia. Microvasc Res. 2019 Mar;122:13-21. doi: 10.1016/j.mvr.2018.10.013. Epub 2018 Nov 3.
- 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.
Pierre ABRAHAM, professor 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 microcirculatory responses in people with Vascular Diseases, 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 1 inclusion and 2 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 7 Nov 2019. 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?
microcirculatory response to local pressure. Measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP). (time frame: 2 hours). 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 NCT02861924, 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 7 Nov 2019.