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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02183779
Recruitment Status : Unknown
Verified December 2015 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : July 8, 2014
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Raynaud Disease Hyperemia Cold Procedure: post-occlusive hyperemia Procedure: cooling box Drug: L-NMMA and Fluconazole dermic injection Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Study Start Date : June 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reynaud
patients with reynaud phenomena
Procedure: post-occlusive hyperemia
Procedure: cooling box
Drug: L-NMMA and Fluconazole dermic injection
Experimental: Healthy
Healthy volunteers
Procedure: post-occlusive hyperemia
Procedure: cooling box
Drug: L-NMMA and Fluconazole dermic injection



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183779


Contacts
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Contact: Jean-Luc CRACOWSKI, MD-PhD +33476769260 JLCracowski@chu-grenoble.fr
Contact: Matthieu ROUSTIT, PharmD-PhD +33476769260 MRoustit@chu-grenoble.fr

Locations
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France
Centre d'investigation clinique CIC1406 Recruiting
GRENOBLE cedex9, France, 38043
Contact: Jean-Luc CRACOWSKI, MD-PhD    33476769260    JLCracowski@chu-grenoble.fr   
Contact: PARIS Adeline, PharmD-PhD    33476767383    AParis@chu-grenoble.fr   
Principal Investigator: Jean-Luc CRACOWSKI, MD-PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Jean-Luc CRACOWSKI, MD-PhD INSERM + University Hospital Grenoble

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02183779    
Other Study ID Numbers: DCIC 14 02
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Keywords provided by University Hospital, Grenoble:
post-occlusive hyperaemia
laser-speckle contrast imaging
epoxyeicosatrienoic acid
nitrous oxide
Additional relevant MeSH terms:
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Hyperemia
Raynaud Disease
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors