PORH and Response to Cold in Raynaud's Phenomenon.

Cold Clinical Trial

— REFRAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02183779
• Other study ID #: DCIC 14 02
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2014
• Last updated: December 8, 2015
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: December 2015
• Source: University Hospital, Grenoble
• Contact: Jean-Luc CRACOWSKI, MD-PhD
• Phone: +33476769260
• Email: JLCracowski[@]chu-grenoble.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cold
• Hyperemia
• Raynaud Disease

Intervention

Procedure:
• post-occlusive hyperemia

• cooling box

Drug:
• L-NMMA and Fluconazole dermic injection

Locations

Country	Name	City	State
France	Centre d'investigation clinique CIC1406	GRENOBLE cedex9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No