PORH and Response to Cold in Raynaud's Phenomenon.

Study Overview
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Brief Summary
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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
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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

Official Title
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Rôle Des Acides Epoxy-eicosatriénoïques et du Monoxyde d'Azote Dans l'hyperhémie Post-occlusive cutanée Digitale et la réponse cutanée au Froid Dans le phénomène de Raynaud Primaire

Conditions
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Raynaud Disease, Hyperemia, Cold

Intervention / Treatment
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* Procedure: post-occlusive hyperemia
* Procedure: cooling box
* Drug: L-NMMA and Fluconazole dermic injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reynaud<br>patients with reynaud phenomena | Procedure: post-occlusive hyperemia<br> <br> Procedure: cooling box<br> <br> Drug: L-NMMA and Fluconazole dermic injection<br> <br> |
| Experimental: Healthy<br>Healthy volunteers | Procedure: post-occlusive hyperemia<br> <br> Procedure: cooling box<br> <br> Drug: L-NMMA and Fluconazole dermic injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post occlusive hyperemia amplitude | post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post occlusive hyperemia amplitude with anesthetic treatment | post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) treated with anesthetic | day1 | 
| cold-induced vasoconstriction amplitude | cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) | day 2 | 
| cold-induced vasoconstriction amplitude with anesthetic treatment | cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) with anesthetic local treatment | day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-occlusive hyperaemia, laser-speckle contrast imaging, epoxyeicosatrienoic acid, nitrous oxide