NCT04032002已完成不适用
Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年11月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- compare the gene expression of B1 and / or B2 monocyte receptors
研究概览
简要总结
The objective is to compare the gene expression of B1 and / or B2 monocyte receptors between patients with hereditary bradykinetic angioedema and control subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •(patients):
- •Patient with inherited bradykinic angioedema due to quantitative or qualitative C1-inhibitor deficiencies, regardless of the frequency or severity of seizures and regardless of their background treatment, with the following diagnostic criteria:
- •C1-inhibitor rate <50% of normal
- •Repeated episodes characteristic of bradykinic angioedema
- •Hereditary nature of the disease.
- •Person who read and understood the newsletter and signed the consent form
- •Person affiliated with a social security scheme
- •Effective contraception in women of childbearing age (negative pregnancy test). For postmenopausal women, a confirmatory diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).
- •Inclusion Criteria (volunteers):
- •Person affiliated with a social security scheme
- •Person who read and understood the newsletter and signed the consent form
- •Effective contraception in women of childbearing age (negative pregnancy test). For postmenopausal women, a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit)
排除标准
- •(patients):
- •Angioedema crisis less than 1 month old
- •Chronic inflammatory disease such as rheumatoid arthritis or Crohn's disease.
- •Acute infection in progress, with or without anti-infectious treatment
- •Contraindication to the use of trinitrin:
- •Hypersensitivity to nitrates or to any of the excipients
- •shock, severe hypotension,
- •obstructive cardiomyopathy,
- •inferior court inferior myocardial infarction with right ventricular extension, except in case of evidence of left ventricular failure,
- •intracranial hypertension,
- •patient treated with sildenafil
- •Pregnant or parturient or breastfeeding woman or lack of proven contraception
- •Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship
- •Patient participating or having participated in another therapeutic trial within one week.
- •Exclusion Criteria (volunteers)
- •Chronic inflammatory disease such as rheumatoid arthritis or Crohn's disease.
- •Acute infection in progress, with or without anti-infectious treatment
- •Contraindication to the use of trinitrin:
- •Hypersensitivity to nitrates or to any of the excipients
- •shock, severe hypotension,
- •obstructive cardiomyopathy,
- •inferior court inferior myocardial infarction with right ventricular extension, except in case of evidence of left ventricular failure,
- •intracranial hypertension,
- •patient treated with sildenafil
- •Pregnant or parturient or breastfeeding woman or lack of proven contraception
- •Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship
- •Person participating or having participated in another therapeutic trial within one week.
研究组 & 干预措施
Patients hereditary bradykinetic angioedema
Other
干预措施: Explorations (Other)
Patients hereditary bradykinetic angioedema
Other
干预措施: Blood samples (Other)
healthy volunteers
Other
干预措施: Explorations (Other)
healthy volunteers
Other
干预措施: Blood samples (Other)
结局指标
主要结局
compare the gene expression of B1 and / or B2 monocyte receptors
时间窗: Day 1
compare between patients with hereditary bradykinetic angioedema and control subjects.
次要结局
未报告次要终点
研究者
研究点 (1)
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