Clinical Trial: PORH and Response to Cold in Raynaud's Phenomenon.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 phénom&#

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 Summary:

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


Sponsor: University Hospital, Grenoble

Current Primary Outcome: post occlusive hyperemia amplitude [ Time Frame: day 1 ]

post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • post occlusive hyperemia amplitude with anesthetic treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: July 1, 2014
Date Started: June 2014
Date Completion: June 2017
Last Updated: December 8, 2015
Last Verified: December 2015