Identification of TRP Channels as New Potential Therapeutic Targets in Primary and Secondary Raynaud's Phenomenon.

NCT03211325 | Completed DMC

• 1 other identifier: 38RC15.164
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators seek to perform a comparative transcriptome analysis of TRP channels residing in the skin between primary and scleroderma secondary Raynaud's phenomenon and healthy subjects.

Conditions

Raynaud's Phenomenon Isolated Primary; Raynaud's Phenomenon (Secondary); Healthy

Keywords

Transient Receptor Potential Channels; Raynaud's Phenomenon Isolated Primary; Raynaud's Phenomenon (Secondary)

Outcome Measures

Primary Outcomes (1)

• Comparison of the expression of mRNA of different TRP channels between the three groups.

  Quantification of the expression of mRNA of TRP channels by RT PCR

  at the moment of the first biopsy

Secondary Outcomes (7)

• Comparison of the expression of mRNA of different TRP channels between the three groups after a loco regional cooling.

  after cooling (2hours after the first biopsy)

• Correlation between the expression of mRNA of different TRP channels and the cutaneous blood flux between the three groups during a loco regional cooling.

  after cooling (2hours after the first biopsy)

• Correlation between the expression of mRNA of different TRP channels and the cutaneous blood flux between the three groups during a loco regional warming at 39°C and 43°C.

  after warming (3 hours after the first biopsy)

• Comparison of the expression of mRNA of different TRP channels between the biopsies of an affected area (surrouding nail area) and a non-affected area (gluteal region) in the three groups.

  at the moment of the biopsies

• Comparison of expressed micro RNA between the three groups.

  at the moment of the first biopsy

Study Arms (3)

Healthy

EXPERIMENTAL

Two sequences of ten healthy volunteers each will be performed : During the first sequence, a biopsy of the gluteal area and another of the surrounding nail area of a finger will be sampled.Then, the cutaneous blood flux of the hand will be recorded at rest and during cooling and warming periods. During the second sequence, two other biopsies of the surrounding nail area of two other fingers will be sampled.

Procedure: Biopsy

Primary Raynaud's phenomenon

EXPERIMENTAL

Two sequences of ten primary Raynaud's syndrome each will be performed : During the first sequence, a biopsy of the gluteal area and another of the surrounding nail area of a finger will be sampled.Then, the cutaneous blood flux of the hand will be recorded at rest and during cooling and warming periods. During the second sequence, two other biopsies of the surrounding nail area of two other fingers will be sampled.

Procedure: Biopsy

Secondary Raynaud's phenomenon

EXPERIMENTAL

Two sequences of ten patients each will be performed : During the first sequence, a biopsy of the gluteal area and another of the surrounding nail area of a finger will be sampled.Then, the cutaneous blood flux of the hand will be recorded at rest and during cooling and warming periods. During the second sequence, two other biopsies of the surrounding nail area of two other fingers will be sampled.

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

Healthy; Primary Raynaud's phenomenon; Secondary Raynaud's phenomenon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers :dated and signed written consent
• Primary Raynaud's patients :
• dated and signed written consent
• subject presenting a primary Raynaud's phenomenon non associated to a connectivite. RP crisis are defined by a succession of caracteristic symptoms : a syncopal phase with distal whitening of the fingers, usually followed by a cyanotic phase, and then a hyperhemic phase with the outbreak of painful redness.The syncopal phase is always present, while the two other phases can be less pronounced, or even absent.
• Sclerodermy secondary Raynaud's patients :
• dated and signed written consent
• subject with Raynaud's phenomenon secondary to systemic sclerosis, according to the 2013 EULAR/ACR criteria.

You may not qualify if:

• Minor person or major person protected by the law
• Social secutrity scheme non-affiliated person or person who cannot pretend to such a scheme
• Pregnant woman, parturient or breast-feeding mother
• Person displaying a digital ulcer or a history of digital ulcer
• Severe concurrent disease found at oral questioning : evolutive cancer, hepatic insufficiency, history of myocardic infarction in the past five years, angina pectoris
• Hemodynamic instability
• Any tobacco consumption
• Any contraindication to the medication used in this trial :
• Anesderm ® (lidocain/procain) : Known hypersensitivity, to local amide linking anesthetic or to any other compound of the cream, congenital methemoglobin porphyria
• Lidocain Aguettant 5 mg/ml without preservative, injectable solution : Known hypersensitivity to lidocain chlorhydrate, to local amide linking anesthetic or to one of its excipients, patients affected with reccurrent porphyrias, administration using intravenous way for children under 5 years
• Xylocain 10 mg/ml epinephrine 0.005 mg/ml, injectable solution : Known hypersensitivity to lidocain chlorhydrate, to local amide linking anesthetic or to one of its excipients, patients affected with reccurrent porphyrias, administration using intravenous way for children under 5 years, linked to the epinephrined compound : intra vascular way, angina pectoris, ventricular rythm troubles, severe arterial hypertension, obstructive cardiomyopathy, hyper thyroidy, anesthesia with local infiltration on the extermities (fingers, penis).
• Kalinox ® (MEOPA) : Need for ventilation in pure oxygen, intracranial hypertension, alteration of consciousness, cranial trauma, pneumothorax, emphysema bubble, submarine diving accident, intestinal gas distension, gas bubble from an eye surgery under 3 months, known and non substituted B12 vitamine or folic acid deficiency, neurological disorder of recent onset and non explained.
• Person deprived from his/her freedom on a judicial or administrative decision, person under a legal protection measure.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU of Grenoble Alpes

Grenoble, Isère, 38700, France

Location

Related Publications (25)

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MeSH Terms

Conditions

Raynaud Disease

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sophie Blaise, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: July 7, 2017
• Study Start: October 18, 2016
• Primary Completion: March 17, 2019
• Study Completion: June 27, 2019
• Last Updated: April 9, 2020

Record last verified: 2019-04

Locations

FR (1)