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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- post occlusive hyperemia amplitude
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neither raynaud's phenomenon or chronic disease for healthy volunteers
- •Raynaud's phenomenon without connective tissue disease for patients in the group "Raynaud"
排除标准
- •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.
研究组 & 干预措施
Reynaud
patients with reynaud phenomena
干预措施: post-occlusive hyperemia (Procedure)
Reynaud
patients with reynaud phenomena
干预措施: cooling box (Procedure)
Reynaud
patients with reynaud phenomena
干预措施: L-NMMA and Fluconazole dermic injection (Drug)
Healthy
Healthy volunteers
干预措施: post-occlusive hyperemia (Procedure)
Healthy
Healthy volunteers
干预措施: cooling box (Procedure)
Healthy
Healthy volunteers
干预措施: L-NMMA and Fluconazole dermic injection (Drug)
结局指标
主要结局
post occlusive hyperemia amplitude
时间窗: day 1
post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)
次要结局
- post occlusive hyperemia amplitude with anesthetic treatment(day1)
- cold-induced vasoconstriction amplitude(day 2)
- cold-induced vasoconstriction amplitude with anesthetic treatment(day 2)