Microvascular FunctionMETHODO-LSCINCT01664572
Methodological Issues and Laser Speckle Contrast Imaging
An observational study of Microvascular Function, run by University Hospital, Angers at 1 site in France.
Trial summary
Microcirculation, especially skin microcirculation, is a window towards systemic vascular function in magnitude and underlying mechanisms. Different techniques have been developed to assess the microcirculation. Among these techniques, laser technology is used to perform non-invasive microvascular assessments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microvascular Function
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Mar 2016
- Phase
- Observational
- 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
Study population: Residents of France
Who may be able to join
- age > 18years old
- subject without any known cardiovascular disease
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methodological Issues of Laser Speckle Contrast Imaging for Studying Microcirculation.
Microcirculation, especially skin microcirculation, is a window towards systemic vascular function in magnitude and underlying mechanisms. Different techniques have been developed to assess the microcirculation. Among these techniques, laser technology is used to perform non-invasive microvascular assessments. Although this technique is widely used, different methodological issues remain. This study aims at defining the way to use lasers for clinical use.
- Conditions
- Microvascular Function
- Keywords
- laser Doppler flowmetry, skin blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Microvascular FunctionStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664572
- Sponsor's protocol ID
- 2012A00458-35
- Acronym
- METHODO-LSCI
- Status last verified
- Jun 2016
- First submitted
- 7 Aug 2012
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Omarjee L, Signolet I, Humeau-Heutier A, Martin L, Henrion D, Abraham P. Optimisation of movement detection and artifact removal during laser speckle contrast imaging. Microvasc Res. 2015 Jan;97:75-80. doi: 10.1016/j.mvr.2014.09.005. Epub 2014 Sep 28.
PubMed 25261716Puissant C, Abraham P, Durand S, Humeau-Heurtier A, Faure S, Leftheriotis G, Mahe G. Assessment of endothelial function by acetylcholine iontophoresis: impact of inter-electrode distance and electrical cutaneous resistance. Microvasc Res. 2014 May;93:114-8. doi: 10.1016/j.mvr.2014.04.001. Epub 2014 Apr 13.
PubMed 24735977Puissant C, Abraham P, Durand S, Humeau-Heurtier A, Faure S, Leftheriotis G, Rousseau P, Mahe G. Reproducibility of non-invasive assessment of skin endothelial function using laser Doppler flowmetry and laser speckle contrast imaging. PLoS One. 2013 Apr 19;8(4):e61320. doi: 10.1371/journal.pone.0061320. Print 2013.
PubMed 23620742
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodological Issues of Laser Speckle Contrast Imaging for Studying Microcirculation.
- ClinicalTrials.gov ID
- NCT01664572
- Acronym / sponsor ID
- METHODO-LSCI / 2012A00458-35
- Conditions
- Microvascular Function
- Keywords
- laser Doppler flowmetry, skin blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Aug 2012 (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.
Microcirculation, especially skin microcirculation, is a window towards systemic vascular function in magnitude and underlying mechanisms. Different techniques have been developed to assess the microcirculation. Among these techniques, laser technology is used to perform non-invasive microvascular assessments. Although this technique is widely used, different methodological issues remain. This study aims at defining the way to use lasers for clinical use.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of France
Key inclusion criteria (2 listed)
- age > 18years old
- subject without any known cardiovascular disease
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Jun 2016.
- Derived from this study: PubMed 25261716Omarjee L, Signolet I, Humeau-Heutier A, Martin L, Henrion D, Abraham P. Optimisation of movement detection and artifact removal during laser speckle contrast imaging. Microvasc Res. 2015 Jan;97:75-80. doi: 10.1016/j.mvr.2014.09.005. Epub 2014 Sep 28.
- Derived from this study: PubMed 24735977Puissant C, Abraham P, Durand S, Humeau-Heurtier A, Faure S, Leftheriotis G, Mahe G. Assessment of endothelial function by acetylcholine iontophoresis: impact of inter-electrode distance and electrical cutaneous resistance. Microvasc Res. 2014 May;93:114-8. doi: 10.1016/j.mvr.2014.04.001. Epub 2014 Apr 13.
- Derived from this study: PubMed 23620742Puissant C, Abraham P, Durand S, Humeau-Heurtier A, Faure S, Leftheriotis G, Rousseau P, Mahe G. Reproducibility of non-invasive assessment of skin endothelial function using laser Doppler flowmetry and laser speckle contrast imaging. PLoS One. 2013 Apr 19;8(4):e61320. doi: 10.1371/journal.pone.0061320. Print 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microvascular Function, 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 2 inclusion and 1 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 14 Jun 2016. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01664572, which also lists 3 linked publications.
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 14 Jun 2016.