NCT02861924

Brief Summary

Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 11, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

July 19, 2016

Last Update Submit

November 5, 2019

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

  • 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).

    2 hours

Study Arms (1)

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.

Other: microcirculatory responses

Interventions

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).

microcirculatory responses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects without vascular pathology

You may not qualify if:

  • pregnancy
  • allergy tape

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49933, France

Location

Related Publications (1)

  • 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.

    PMID: 30399363DERIVED

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Pierre ABRAHAM, professor

    UH ANGERS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

August 10, 2016

Study Start

October 11, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2019

Last Updated

November 7, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)