Back to resultsPORH and Response to Cold in Raynaud's Phenomenon. (REFRAIN)
Primary Purpose
Raynaud Disease, Hyperemia, Cold
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
post-occlusive hyperemia
cooling box
L-NMMA and Fluconazole dermic injection
Sponsored by
About this trial
This is an interventional basic science trial for Raynaud Disease focused on measuring post-occlusive hyperaemia, laser-speckle contrast imaging, epoxyeicosatrienoic acid, nitrous oxide
Eligibility 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.
Sites / Locations
- Centre d'investigation clinique CIC1406Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Reynaud
Healthy
Arm Description
patients with reynaud phenomena
Healthy volunteers
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
cold-induced vasoconstriction amplitude
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
cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) with anesthetic local treatment
Full Information
NCT ID
NCT02183779
First Posted
July 1, 2014
Last Updated
December 8, 2015
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT02183779
Brief Title
PORH and Response to Cold in Raynaud's Phenomenon.
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud Disease, Hyperemia, Cold
Keywords
post-occlusive hyperaemia, laser-speckle contrast imaging, epoxyeicosatrienoic acid, nitrous oxide
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reynaud
Arm Type
Experimental
Arm Description
patients with reynaud phenomena
Arm Title
Healthy
Arm Type
Experimental
Arm Description
Healthy volunteers
Intervention Type
Procedure
Intervention Name(s)
post-occlusive hyperemia
Intervention Type
Procedure
Intervention Name(s)
cooling box
Intervention Type
Drug
Intervention Name(s)
L-NMMA and Fluconazole dermic injection
Primary Outcome Measure Information:
Title
post occlusive hyperemia amplitude
Description
post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)
Time Frame
day 1
Secondary Outcome Measure Information:
Title
post occlusive hyperemia amplitude with anesthetic treatment
Description
post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) treated with anesthetic
Time Frame
day1
Title
cold-induced vasoconstriction amplitude
Description
cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)
Time Frame
day 2
Title
cold-induced vasoconstriction amplitude with anesthetic treatment
Description
cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) with anesthetic local treatment
Time Frame
day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Luc CRACOWSKI, MD-PhD
Phone
+33476769260
Email
JLCracowski@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu ROUSTIT, PharmD-PhD
Phone
+33476769260
Email
MRoustit@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc CRACOWSKI, MD-PhD
Organizational Affiliation
INSERM + University Hospital Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'investigation clinique CIC1406
City
GRENOBLE cedex9
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc CRACOWSKI, MD-PhD
Phone
33476769260
Email
JLCracowski@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
PARIS Adeline, PharmD-PhD
Phone
33476767383
Email
AParis@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Jean-Luc CRACOWSKI, MD-PhD
12. IPD Sharing Statement
Learn more about this trial
PORH and Response to Cold in Raynaud's Phenomenon.
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