NCT02721472已完成不适用
Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Theravia
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Comparison of plasma DNA levels in patients with a reactive hyperaemia index (RHI) < 1.67 (endothelial dysfunction) assessed by Endo-PAT 2000 versus those recorded in patients with a RHI ≥ 1.67 (no endothelial dysfunction)
研究概览
简要总结
The purpose of this study is to evaluate the relationship between plasma DNA levels and micro- and macro-circulatory vascular remodelling in patients with sickle cell disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Age ≥ 18 years.
- •Homozygous SS or Sß0 sickle cell disease patients.
- •Seen in consultation for an annual clinical and para-clinical evaluation of his/her disease.
- •Stable clinical condition of the disease defined as the absence of severe vaso-occlusive crises (requiring hospitalisation or a visit to the emergency unit) in the previous month and absence of transfusion in the previous 3 months.
排除标准
- •Other haemoglobinopathy
- •Known diabetes.
- •Recent administration of an anticoagulant treatment at curative doses (< 48h before inclusion), or platelet-inhibiting drugs (less than 1 week prior to inclusion).
- •Recent transfusion (less than 3 months prior to inclusion).
- •Pregnancy or post-partum (first 40 days after giving birth).
- •Recent consumption of alcohol (less than 10h), coffee (less than 3h), and tobacco (less than 36h) before inclusion.
- •Known infection with hepatitis B, C, and HIV infection.
- •Known cancer or progressive blood disease.
- •Known haemostasis or coagulation disorders.
- •Progressive inflammatory or infectious diseases.
- •Recent history (dating less than 3 months) of venous (pulmonary embolism, deep venous thrombosis) or arterial (acute coronary syndrome, stroke, peripheral arterial ischaemia) thromboembolic event.
- •Adult patients subject to legal protection measures.
- •Patients already involved in a therapeutic protocol.
- •Patients not affiliated to a social security system.
- •Non-inclusion criteria related to the technical requirements of the Endo-PAT:
- •Known cardiac arrhythmia.
- •Severe Raynaud's syndrome.
- •Hand or arm deformity that prevents an EndoPAT analysis.
结局指标
主要结局
Comparison of plasma DNA levels in patients with a reactive hyperaemia index (RHI) < 1.67 (endothelial dysfunction) assessed by Endo-PAT 2000 versus those recorded in patients with a RHI ≥ 1.67 (no endothelial dysfunction)
时间窗: 1 days
次要结局
- Relationship between plasma DNA levels and cerebral micro- and macro-angiopathy assessed by CT angiography or MRI angiography and transcranial Doppler ultrasound(1 day)
- Relationship between plasma DNA levels and cardiac damages(1 day)
- Relationship between plasma DNA levels and pulmonary blood pressure(1 day)
- Relationship between plasma DNA levels and macrocirculatory vascular measurements(2 days)
- Relationship between plasma DNA levels and nephropathy(1 day)
- Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition(1 day)
研究者
研究点 (2)
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