Raynaud Disease, Scleroderma, Systemic
Conditions
Keywords
healthy subject, hand blood flow, laser speckle contrast imaging
Brief summary
The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of the hand with Laser speckle contrast imaging discriminate between patients with systemic sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.
Detailed description
Microvascular dysfunction is a key event in the pathogenesis of systemic sclerosis. There are currently no test measuring it in clinical practice. Response to humeral occlusion is interesting and this response has been studied with laser Doppler flowmetry. More recently, laser imaging has been used analysing the granularity of the laser: laser Speckle Contrast Imaging which allow combining high temporal resolution to high spatial resolution. The investigators proposed, in this study, to compare this imaging at basal and after post-occlusive hyperaemia of dorsal and palmar face of hand in 3 groups: healthy subjects, primary Raynaud's phenomenon and systemic sclerosis.
Interventions
PROCEDURElaser speckle contrast imaging
blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.
PROCEDURECooling
blood flow of the hand recording during 30 minutes in a cooling-box
Sponsors
University Hospital, Grenoble
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects: * Man ou woman 18 years old or more. * Without Raynaud's phenomenon or systemic sclerosis. Raynaud's phenomenon subjects: * Man ou woman 18 years old or more. * with primary Raynaud's phenomenon. Systemic sclerosis: * Man ou woman 18 years old or more. * systemic sclerosis in accordance to Leroy's classification.
Exclusion criteria
* active digital ulceration * Bosentan, iloprost ou sildenafil treatment * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-occlusive hyperemia response between groups | 30 minutes | The range of post-occlusive hyperemia response will be compared between the 3 arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| abnormal post-occlusive hyperemia response and finger pad scars | 30 minutes | comparison of range of post-occlusive hyperemia response with or without finger pad scars. |
| post-occlusive hyperemia response between zones | 30 minutes | The range of post-occlusive hyperemia response will be compared between zones. |
| Entropy and Fourier transform | 30 minutes | The interest of the signal analyses to distinguish systemic sclerosis, raynaud's phenomenon and healthy subjects will be studied with entropy and Fourier transform. |
| Post-occlusive hyperemia response between the 2 faces | 30 minutes | The Range of post-occlusive hyperemia response will be compared between the 2 hand faces (palmar and dorsal). |
Other
| Measure | Time frame | Description |
|---|---|---|
| blood flow after cooling in each group | 30 minutes | The range of blood flow after cooling on pulpar and dorsal face of hand will be compared between the 3 groups. |
| reproductibility of hand cooling | Day 0 and Day 4 | The reproductibility of the measure of blood flow after cooling will be studied twice, at day0 and 4 days later. |
| Blood flow after cooling between groups | 30 minutes | Range of the diminution of blood flow in palmar and dorsal hand faces will be compared in the 3 groups |
Countries
France
Outcome results
None listed