PORH and Response to Cold in Raynaud's Phenomenon. (REFRAIN)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Raynaud Disease; Hyperemia; Cold

Treatments: Drug: L-NMMA and Fluconazole dermic injection; Procedure: cooling box; Procedure: post-occlusive hyperemia

Study type: Interventional

Funder types: Other

Identifiers

NCT02183779

DCIC 14 02

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Reynaud

Experimental group

Description:

patients with reynaud phenomena

Treatment:

Procedure: post-occlusive hyperemia

Drug: L-NMMA and Fluconazole dermic injection

Procedure: cooling box

Healthy

Experimental group

Description:

Healthy volunteers

Treatment:

Procedure: post-occlusive hyperemia

Drug: L-NMMA and Fluconazole dermic injection

Procedure: cooling box