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

December 8, 2015 updated by: University Hospital, Grenoble

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • GRENOBLE cedex9, France, 38043
        • Recruiting
        • Centre d'investigation clinique CIC1406
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Luc CRACOWSKI, MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reynaud
patients with reynaud phenomena
Experimental: Healthy
Healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day1
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)
day 2
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
day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jean-Luc CRACOWSKI, MD-PhD, INSERM + University Hospital Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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