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Locally Applied Pressure-induced Vasodilatation (LAV)

Primary Purpose

Vascular Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
microcirculatory responses
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • subjects without vascular pathology

Exclusion Criteria:

  • pregnancy
  • allergy tape

Sites / Locations

  • CHU Angers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

microcirculatory responses

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 19, 2016
Last Updated
November 5, 2019
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02861924
Brief Title
Locally Applied Pressure-induced Vasodilatation
Acronym
LAV
Official Title
Réponse à l'Application d'Une Pression Locale en Laser Speckle Imaging Locally Applied Pressure-induced Vasodilatation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 11, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
microcirculatory responses
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
microcirculatory responses
Intervention Description
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).
Primary Outcome Measure Information:
Title
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).
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: subjects without vascular pathology Exclusion Criteria: pregnancy allergy tape
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre ABRAHAM, professor
Organizational Affiliation
UH ANGERS
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30399363
Citation
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.
Results Reference
derived

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Locally Applied Pressure-induced Vasodilatation

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