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临床试验/NCT02210130
NCT02210130已完成不适用

Measure of Specific Determinants of the Cerebral Small Vessel Disease in HIV+ Patients

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
163
试验地点
1
主要终点
determinants of CSCV in patients with HIV

研究概览

简要总结

Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability in the general population, secondary to the accumulation of asymptomatic elementary lesions. CSVD is directly correlated with age and cardiovascular risk factors and therefore would be challenging in term of public health care in the future. While HIV patients share the same cardiovascular risk factors and they are often diagnosed with cognitive impairment and frailty, CSVD has not been yet described in this population.

The global aim is to study and describe the CSVD in the HIV+ population by: (1) correlating the CSVD and the macro-vascular disease of the head and brain; (2) correlating the CSVD with the ocular (structural sentinel organ) and kidney (functional sentinel organ) micro-vascular disease.

HIV+/CSVD+ patients will have a complementary work-up with conventional MRI/MRA, thorough vascular explorations, and neurologic examination to evaluate the severity of the CSVD, the macro-vascular disease and the cerebral atrophy. They will have a full ophthalmic examination and specific kidney explorations to evaluate the micro-vascular disease of this two sentinel organs. The same number of HIV+/CSVD- matched patients will have the same work-up.

We are expecting to show the relationship between CSVD and cardiovascular risk factors in order to propose specific prevention. We will correlate the CSVD with the neurologic and cognitive function as it is already proved in the general population. We will correlate the CSVD with the ocular and kidney micro-vascular disease to propose fast, easy and cheap screening tools for the CSVD in the HIV+ population.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 50 years old
  • chronic HIV seropositive patient infected for at least 5 years
  • antiretroviral therapy
  • plasmatic HIV viral load <40 copies/ml for at least one year with one authorized blip < 1000 copies/ml per year
  • cerebral small vessels disease (patients) or not (controls)

排除标准

  • Co-infection VHC
  • known antecedent of stroke
  • documented neurologic complication of HIV
  • drug user
  • glomerular filtration rate< 15 mL/mn
  • diabetic patient with kidney or retin complications
  • systolic blood pressure≥ 180 and/or diastolic blood pressure≥ 110 mmHg

结局指标

主要结局

determinants of CSCV in patients with HIV

时间窗: baseline

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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