NCT02183779

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

2.3 years

First QC Date

July 1, 2014

Last Update Submit

December 8, 2015

Conditions

Raynaud DiseaseHyperemiaCold

Keywords

post-occlusive hyperaemialaser-speckle contrast imagingepoxyeicosatrienoic acidnitrous oxide

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • post occlusive hyperemia amplitude with anesthetic treatment

    day1

  • cold-induced vasoconstriction amplitude

    day 2

  • cold-induced vasoconstriction amplitude with anesthetic treatment

    day 2

Study Arms (2)

Reynaud

EXPERIMENTAL

patients with reynaud phenomena

Procedure: post-occlusive hyperemiaProcedure: cooling boxDrug: L-NMMA and Fluconazole dermic injection

Healthy

EXPERIMENTAL

Healthy volunteers

Procedure: post-occlusive hyperemiaProcedure: cooling boxDrug: L-NMMA and Fluconazole dermic injection

Interventions

post-occlusive hyperemiaPROCEDURE
HealthyReynaud
cooling boxPROCEDURE
HealthyReynaud
L-NMMA and Fluconazole dermic injectionDRUG
HealthyReynaud

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neither raynaud's phenomenon or chronic disease for healthy volunteers
  • Raynaud's phenomenon without connective tissue disease for patients in the group "Raynaud"

You may not qualify if:

  • History of axillary dissection , trauma or surgery
  • History of thromboembolic disease or thrombophilia
  • Minor or law-protected major
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'investigation clinique CIC1406

Grenoble Cedex9, 38043, France

RECRUITING

MeSH Terms

Conditions

Raynaud DiseaseHyperemiaCommon Cold

Interventions

omega-N-Methylarginine

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ArginineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Jean-Luc CRACOWSKI, MD-PhD

    INSERM + University Hospital Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Luc CRACOWSKI, MD-PhD

CONTACT

+33476769260JLCracowski@chu-grenoble.fr

Matthieu ROUSTIT, PharmD-PhD

CONTACT

+33476769260MRoustit@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 8, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2016

Study Completion

June 1, 2017

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

FR(1)