PORH and Response to Cold in Raynaud's Phenomenon.

Not Applicable

• Conditions: Hyperemia; Raynaud Disease; Cold
• Interventions: Procedure: post-occlusive hyperemia; Procedure: cooling box; Drug: L-NMMA and Fluconazole dermic injection

• Registration Number: NCT02183779
• Lead Sponsor: University Hospital, Grenoble

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

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09
• Primary Completion: 2016-10
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reynaud	L-NMMA and Fluconazole dermic injection	patients with reynaud phenomena
Reynaud	cooling box	patients with reynaud phenomena
Healthy	cooling box	Healthy volunteers
Reynaud	post-occlusive hyperemia	patients with reynaud phenomena
Healthy	L-NMMA and Fluconazole dermic injection	Healthy volunteers
Healthy	post-occlusive hyperemia	Healthy volunteers

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre d'investigation clinique CIC1406; 🇫🇷 GRENOBLE cedex9, France