Cold, Hyperemia, Raynaud Disease
Conditions
Keywords
post-occlusive hyperaemia, laser-speckle contrast imaging, epoxyeicosatrienoic acid, nitrous oxide
Brief summary
The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.
Detailed description
The main objective of the study is to determine if implication of epoxy-eicosatriénoïques acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers. Healthy controls and patients will undergo 3 visits
Interventions
PROCEDUREpost-occlusive hyperemia
PROCEDUREcooling box
DRUGL-NMMA and Fluconazole dermic injection
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Neither raynaud's phenomenon or chronic disease for healthy volunteers * Raynaud's phenomenon without connective tissue disease for patients in the group Raynaud
Exclusion criteria
* History of axillary dissection , trauma or surgery * History of thromboembolic disease or thrombophilia * Minor or law-protected major * Exclusion period in another study * No affiliation to medicare * Pregnant, parturient or breasting woman * Concomitant serious disease: progressive cancer, liver failure, history of myocardial infarction less than 5 years, angor * Smoking in the 6 last months * Person deprived of liberty by a legal or administrative decision, person under legal protection * Maximal annual indemnification reached.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post occlusive hyperemia amplitude | day 1 | post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post occlusive hyperemia amplitude with anesthetic treatment | day1 | post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) treated with anesthetic |
| cold-induced vasoconstriction amplitude | day 2 | cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) |
| cold-induced vasoconstriction amplitude with anesthetic treatment | day 2 | cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) with anesthetic local treatment |
Countries
France
Contacts
Primary ContactJean-Luc CRACOWSKI, MD-PhD
Backup ContactMatthieu ROUSTIT, PharmD-PhD
Outcome results
None listed